Data / Medical devices / Germany / ABBOTT GmbH

ABBOTT GmbH: FDA-registered device maker in Wiesbaden Hesse, Germany, 111 510(k) clearances and 9 PMA approvals

Name: ABBOTT GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ABBOTT GmbH is registered with the FDA (registration 3002809144) in Wiesbaden Hesse, Germany. It lists 137 device types. The FDA files 111 510(k) clearances and 9 PMA approvals under its listings, the newest dated September 23, 2026. 17 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this one Watch ABBOTT GmbH

FDA registration number: 3002809144
Address: Max-Planck-Ring 2, Wiesbaden Hesse, Germany, 65205
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: December 13, 1977
Registered through: 2027
Brand names listed: 20X SSC, 500g, ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ACE Reagent (LN 06U8225), ACE Reagent (LN 06U8625), ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Folic, Radioimmunoassay	CGN	2	Exporter to the US	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Exporter to the US	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Exporter to the US	accessdata.fda.gov
Acid, Uric, Uricase (U.V.)	CDO	1	Exporter to the US	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Exporter to the US	accessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	2	Exporter to the US	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Exporter to the US	accessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Exporter to the US	accessdata.fda.gov
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	PTF	2	Exporter to the US	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Exporter to the US	accessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, Lithium	NDW	2	Exporter to the US	accessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology Assays	QCH	2	Manufacturer	accessdata.fda.gov
Bathophenanthroline, Iron Binding Capacity	JQF	1	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Exporter to the US	accessdata.fda.gov
Brain Trauma Assessment Test	QAT	2	Exporter to the US	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Exporter to the US	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	Exporter to the US	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Exporter to the US	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Exporter to the US	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Exporter to the US	accessdata.fda.gov
Calibrator, Primary	JIS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Exporter to the US	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Exporter to the US	accessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl Transpeptidase	JPZ	1	Exporter to the US	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Exporter to the US	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Exporter to the US	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Exporter to the US	accessdata.fda.gov
Detergent	JCB	1	Exporter to the US	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Exporter to the US	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Exporter to the US	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Exporter to the US	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Manufacturer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Exporter to the US	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Exporter to the US	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Exporter to the US	accessdata.fda.gov
Enzymatic Method, Ammonia	JIF	1	Exporter to the US	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Exporter to the US	accessdata.fda.gov
Fixative, Alcohol Containing	LDZ	1	Exporter to the US	accessdata.fda.gov
Fluid, Diluting, White-Cell	GGJ	1	Exporter to the US	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	2	Exporter to the US	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Theophylline	LGS	2	Exporter to the US	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Exporter to the US	accessdata.fda.gov
Fluorometric, Cortisol	JFT	2	Exporter to the US	accessdata.fda.gov
Galectin-3 In Vitro Diagnostic Assay	OSX	2	Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Exporter to the US	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Exporter to the US	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Exporter to the US	accessdata.fda.gov
Iga, Antigen, Antiserum, Control	CZP	2	Exporter to the US	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Exporter to the US	accessdata.fda.gov
Igm, Antigen, Antiserum, Control	DFT	2	Exporter to the US	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Exporter to the US	accessdata.fda.gov
Indirect Copper Assay, Ceruloplasmin	JFR	2	Exporter to the US	accessdata.fda.gov
Kit, Serological, Negative Control	MJY	1	Manufacturer	accessdata.fda.gov
Kit, Serological, Positive Control	MJX	1	Manufacturer	accessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	LOK	3	Exporter to the US	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Exporter to the US	accessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	2	Exporter to the US	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Exporter to the US	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Exporter to the US	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Exporter to the US	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Exporter to the US	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Exporter to the US	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Exporter to the US	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Exporter to the US	accessdata.fda.gov
Ovarian Adnexal Mass Assessment Score Test System	ONX	2	Specification developer	accessdata.fda.gov
Ph Buffer	JCC	1	Exporter to the US	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Exporter to the US	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Exporter to the US	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Exporter to the US	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Exporter to the US	accessdata.fda.gov
Procalcitonin Assay	PRI	2	Exporter to the US	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Exporter to the US	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Exporter to the US	accessdata.fda.gov
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	JRS	1	Exporter to the US	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Radioassay, Angiotensin Converting Enzyme	KQN	2	Exporter to the US	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Exporter to the US	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Exporter to the US, Specification developer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Exporter to the US	accessdata.fda.gov
Romanowsky Stains	GJL	1	Exporter to the US	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Slides, Microscope	KEW	1	Exporter to the US	accessdata.fda.gov
Stain, Reticulocyte	GJH	1	Exporter to the US	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Specification developer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Exporter to the US	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Exporter to the US	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Specification developer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Exporter to the US	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Exporter to the US	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Exporter to the US	accessdata.fda.gov
Test, Cystatin C	NDY	2	Exporter to the US	accessdata.fda.gov
Test, Epithelial Ovarian Tumor Associated Antigen (He4)	OIU	2	Specification developer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Specification developer	accessdata.fda.gov
Test, Equipment, Automated Bloodborne Pathogen	MZA	N	Exporter to the US	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Specification developer	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Exporter to the US	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Exporter to the US	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Exporter to the US	accessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	JIQ	1	Exporter to the US	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 111.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 23, 2026	K262156	Anti-HCV Next	MZO	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
April 28, 2026	K252424	Anti-HCV Next	MZO	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
October 24, 2025	K252357	Glucose2	CFR	Substantially Equivalent	Abbott Ireland	accessdata.fda.gov
July 9, 2025	K243500	ARCHITECT iGentamicin	LCD	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 20, 2025	K243168	Alinity i Rubella IgG	LFX	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 16, 2025	K242585	Cystatin C	NDY	Substantially Equivalent	SENTINEL CH. SpA	accessdata.fda.gov
August 30, 2024	K233932	Alinity i Toxo IgM	LGD	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
July 31, 2024	K233541	ARCHITECT Active-B12 (Holotranscobalamin)	CDD	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.	accessdata.fda.gov
September 29, 2023	K232669	TBI	QAT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
August 10, 2023	K222850	HAVAb IgG II	LOL	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
July 21, 2023	K223317	Alkaline Phosphatase2	CJE	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
June 5, 2023	K230937	Alinity i Total ß-hCG Reagent Kit, GLP systems Track	DHA	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 4, 2023	K230994	Alinity i STAT High Sensitivity Troponin-I	MMI	Substantially Equivalent	Abbott Laboratories Diagnostics Division	accessdata.fda.gov
March 2, 2023	K223602	Traumatic brain injury (TBI) test	QAT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 29, 2022	K223324	Total Bilirubin2	CIG	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
October 27, 2022	K220949	Architect CMV IgG	LFZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 30, 2022	K203597	Cholesterol2	CHH	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
May 26, 2022	K210633	Amylase2	JFJ	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
May 19, 2022	K210596	ARCHITECT Toxo IgG	LGD	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 19, 2022	K202525	Alinity i STAT High Sensitivity Troponin-I	MMI	Substantially Equivalent	Abbott Laboratories Diagnostics Division	accessdata.fda.gov
March 22, 2022	K210452	Creatinine2	CGX	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
March 18, 2022	K203530	Albumin BCP2	CJW	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
March 10, 2022	K213486	GLP systems Track	JGS	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
November 23, 2021	K203248	Albumin BCG2	CIX	Substantially Equivalent	Abbott Ireland Diagnostics Division	accessdata.fda.gov
November 8, 2019	K192118	CRP Vario	DCK	Substantially Equivalent	SENTINEL CH. SpA	accessdata.fda.gov
September 13, 2019	K191595	ARCHITECT STAT High Sensitivity Troponin-I	MMI	Substantially Equivalent	Abbott Laboratories Diagnostics Division	accessdata.fda.gov
March 15, 2019	K190294	CELL-DYN Emerald 22 AL System	GKZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 27, 2018	K173833	CRP Vario	NQD	Substantially Equivalent	SENTINEL CH. SpA	accessdata.fda.gov
September 12, 2018	K181748	Magnesium	JGJ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
October 27, 2017	K173122	Abbott Architect Free T4	CEC	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
October 23, 2017	K170317	Alinity i Total ß-hCG Reagent Kit, Alinity i System	DHA	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
October 19, 2017	K170316	ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM	CFR	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 1, 2017	K170652	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls	PRI	Substantially Equivalent	Fisher Diagnostics	accessdata.fda.gov
March 31, 2017	K162530	Multichem IA Plus	JJY	Substantially Equivalent	Techno-Path Manufacturing	accessdata.fda.gov
February 15, 2017	K170160	Abbott ARCHITECT Free T3	JIT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
October 26, 2016	K162514	Multichem A1c	JJX	Substantially Equivalent	Technopath Manufacturing	accessdata.fda.gov
August 12, 2016	K153375	ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls	MRG	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 15, 2016	K153730	ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control	LIP	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
April 28, 2016	K151502	ARCHITECT ROMA	ONX	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
July 10, 2015	K151566	Abbott ARCHITECT Total T4 Calibrators	JIT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 22, 2015	K140654	Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls	PDJ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 23, 2014	K140436	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS	OSX	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
December 19, 2013	K132400	LP(A) CALIBRATORS, AND LP(A) CONTROLS	JIT	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
October 22, 2013	K132751	MULTICHEM S PLUS / S PLUS (ASSAYED)	JJY	Substantially Equivalent	Techno-Path Manufacturing , Ltd.	accessdata.fda.gov
October 15, 2013	K131993	MULTICHEM U	JJY	Substantially Equivalent	Techno-Path Manufacturing , Ltd.	accessdata.fda.gov
September 25, 2013	K131992	MULTICHEM P	JJY	Substantially Equivalent	Techno-Path Manufacturing , Ltd.	accessdata.fda.gov
September 20, 2013	K132174	MULTICHEM WBT	DIF	Substantially Equivalent	Techno-Path Manufacturing , Ltd.	accessdata.fda.gov
September 20, 2013	K132091	MULTICHEM IA AND IA PLUS	JJY	Substantially Equivalent	Techno-Path Manufacturing , Ltd.	accessdata.fda.gov
January 14, 2013	K123372	ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR	JIX	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
November 27, 2012	K123379	ABBOTT ARCHITECT FREE T4	CEC	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 11, 2012	K120009	TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)	CDZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 28, 2012	K113704	ARCHITECT HAVAB-G	LOL	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 17, 2012	K121314	ARCHITECT B12	CDD	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 22, 2011	K110381	CELL-DYN EMERALD 22 SYSTEM	GKZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 19, 2011	K112443	ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)	CDD	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.	accessdata.fda.gov
October 14, 2011	K103627	ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS	KLT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
June 10, 2011	K111023	ABBOTT ARCHITECT LH CALIBRATORS	JIT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
April 1, 2011	K102699	ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS	LCD	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
March 18, 2010	K093957	ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,	OIU	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
March 5, 2010	K092740	ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74	CGN	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 25, 2009	K083868	ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35	NHX	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.	accessdata.fda.gov
August 6, 2009	K090358	ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35	LEG	Substantially Equivalent	Abbott Laboratories, Inc.	accessdata.fda.gov
February 4, 2009	K081495	CELL-DYN EMERALD SYSTEM	GKZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 22, 2008	K082953	ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01	KXT	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
September 26, 2008	K081231	ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33	DLZ	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 11, 2008	K080696	ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01	DIP	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
September 3, 2008	K082141	ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10	JIT	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
June 19, 2008	K073634	MULTIGENT CREATININE (ENZYMATIC) ASSAY	JFY	Substantially Equivalent	SENTINEL CH. SpA	accessdata.fda.gov
April 24, 2008	K073640	ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS	LPS	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.	accessdata.fda.gov
March 19, 2008	K072036	ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01	LEH	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
August 2, 2007	K070987	SENTINEL LITHIUM ASSAY	NDW	Substantially Equivalent	SENTINEL CH. SpA	accessdata.fda.gov
June 19, 2007	K063232	ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01	CEW	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
June 8, 2007	K070810	ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)	LGS	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
May 23, 2007	K070971	MODIFICATION TO SENTINEL CLIN CHEM CAL	JIX	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
April 16, 2007	K063329	ABBOTT ARCHITECT HAVAB-M	LOL	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
January 23, 2007	K060818	ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01	CDZ	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
September 22, 2006	K062204	ARCHITECT CORTISOL ASSAY	JFT	Substantially Equivalent	Seradyn, Inc.	accessdata.fda.gov
July 18, 2006	K052407	ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS	JZO	Substantially Equivalent	Fisher Diagnostics	accessdata.fda.gov
May 25, 2006	K060964	ARCHITECT BNP ASSAY, MODEL 8K28	NBC	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
May 10, 2006	K052308	ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM	JZO	Substantially Equivalent	Fisher Diagnostics	accessdata.fda.gov
January 26, 2006	K060027	ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)	JJX	Substantially Equivalent	Biokit, S.A.	accessdata.fda.gov
November 25, 2005	K051114	SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY	JIF	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
November 17, 2005	K051111	SENTINEL UIBC LIQUID	JQF	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
October 25, 2005	K052000	ARCHITECT CA 19-9XR ASSAY	NIG	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
October 21, 2005	K051456	SENTINEL CERULOPLASMIN	JFR	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
August 25, 2005	K051115	SENTINEL IRON LIQUID	JIY	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
August 8, 2005	K050836	CRP DIAGNOSTIC ASSAY	DCK	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
July 25, 2005	K051457	SENTINEL PLASMAPROTEINS CAL 3X	JIX	Substantially Equivalent	Sentinel Ch. Srl	accessdata.fda.gov
January 24, 2005	K042924	ARCHITECT STAT MYO IMMUNOASSAY	DDR	Substantially Equivalent	Fisher Diagnostics	accessdata.fda.gov
December 22, 2004	K042732	ARCHITECT CA 15-3 ASSAY	MOI	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
November 19, 2004	K042731	ARCHITECT CA 125 II ASSAY	LTK	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
August 18, 2004	K041687	ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR	JJX	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
July 21, 2004	K041596	ARCHITECT STAT CK-MB IMMUNOASSAY	JHX	Substantially Equivalent	Fisher Diagnostics	accessdata.fda.gov
October 6, 2003	K032458	ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT	JIT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
April 11, 2003	K030320	WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET	JIS	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
January 15, 2003	K024067	RHEUMATOID FACTOR (RF)	DHR	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
May 11, 1999	K990774	ABBOTT ARCHITECT CEA	DHX	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
January 29, 1999	K983289	APOLIPOPROTEIN A1	DER	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
January 26, 1999	K983281	APOB	DFC	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
December 7, 1998	K983759	ABBOTT ARCHITECT FERRITIN	DBF	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 10, 2022	P210003	ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit	LOM	13	April 3, 2025	accessdata.fda.gov
November 28, 2012	P120008	ABBOTT ARCHITECT AFP ASSAY	LOK	32	May 11, 2026	accessdata.fda.gov
April 12, 2012	P110029	ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS	LOM	51	April 3, 2025	accessdata.fda.gov
April 10, 2009	P080023	ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS	SEI	46	April 3, 2025	accessdata.fda.gov
November 6, 2007	P060035	ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS	SEI	43	April 3, 2025	accessdata.fda.gov
June 7, 2006	P050042	ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL	MZO	47	December 15, 2021	accessdata.fda.gov
June 1, 2006	P050051	ABBOTT ARCHITECT AUSAB	SEI	60	April 3, 2025	accessdata.fda.gov
February 5, 2004	P980007	AXSYM FREE PSA	MTG	55	February 12, 2026	accessdata.fda.gov
September 25, 1991	P910007	AXSYM TOTAL PSA & ARCHITECT TOTAL PSA	MTF	67	February 23, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 4, 2024	94205	Class II	Ongoing	ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35	Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes	accessdata.fda.gov
June 19, 2020	85914	Class II	Terminated	Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below	Quality Control results were not properly evaluated for QC failures.	accessdata.fda.gov
May 12, 2020	85686	Class II	Terminated	Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.	There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.	accessdata.fda.gov
April 24, 2020	85590	Class II	Ongoing	ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.	Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.	accessdata.fda.gov
March 9, 2020	85238	Class II	Terminated	ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.	An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.	accessdata.fda.gov
January 24, 2020	84831	Class II	Terminated	LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.	Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.	accessdata.fda.gov
November 7, 2019	84238	Class II	Terminated	ARCHITECT HAVAB-G Calibrator, REF 6L27-01	Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpre	accessdata.fda.gov
October 23, 2019	84140	Class II	Terminated	Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada	Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotatio	accessdata.fda.gov
September 16, 2019	83847	Class II	Ongoing	Alinity ci Level Sensor, Bulk Solution	Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.	accessdata.fda.gov
June 10, 2019	83235	Class II	Terminated	Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. T	Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.	accessdata.fda.gov
May 21, 2019	82974	Class II	Terminated	The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * Alinity ci-series * *SYSTEM CONTROL MODULE Product Usage	All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).	accessdata.fda.gov
April 15, 2019	82644	Class II	Terminated	Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing	Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.	accessdata.fda.gov
April 5, 2019	82595	Class II	Terminated	Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automat	Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.	accessdata.fda.gov
March 7, 2019	82475	Class II	Terminated	Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02, and Accessory Kit, Ali	Potential performance issues in the Alinity-ci software version 2.5.1	accessdata.fda.gov
February 26, 2019	82511	Class II	Terminated	Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest pr	The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.	accessdata.fda.gov
December 20, 2018	81916	Class II	Terminated	Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random a	Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.	accessdata.fda.gov
December 14, 2017	79482	Class II	Terminated	ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT i	Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.	accessdata.fda.gov

Compare with other makers

Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.