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Siemens Healthcare Diagnostics Manufacturing Ltd.: FDA-registered device maker in SWORDS Dublin(County), Ireland, 12 510(k) clearances

Name: Siemens Healthcare Diagnostics Manufacturing Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Siemens Healthcare Diagnostics Manufacturing Ltd. is registered with the FDA (registration 8020888) in SWORDS Dublin(County), Ireland. It lists 51 device types. The FDA files 12 510(k) clearances under its listings, the newest dated July 13, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 8020888
FEI number: 3007019572
Address: Chapel Lane, SWORDS Dublin(County), Ireland, --
Owner or operator: SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
Roles: Manufacturer
First device listed: February 7, 2000
Registered through: 2027
Brand names listed: ADVIA 120, ADVIA 120/2120, ADVIA Centaur, ADVIA Centaur Acid and Base Reagents, ADVIA Centaur CP Analyzer, ADVIA Centaur Total Triiodothyronine (T3), ADVIA Centaur Total Triiodothyronine Diluent (T3 DIL), ADVIA Centaur Total Triiodothyronine Master Curve Material (T3 MCM) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Folic, Radioimmunoassay	CGN	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	Manufacturer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Manufacturer	accessdata.fda.gov
Counter, Cell, Automated (Particle Counter)	GKL	2	Manufacturer	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Manufacturer	accessdata.fda.gov
Device, General Purpose, Hematology	LOQ	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Manufacturer	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	2	Manufacturer	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Theophylline	LGS	2	Manufacturer	accessdata.fda.gov
Fluorescent Immunoassay, Tobramycin	LCR	2	Manufacturer	accessdata.fda.gov
Fluorometric, Cortisol	JFT	2	Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Manufacturer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Manufacturer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Manufacturer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Manufacturer	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 13, 2023	K222116	Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
August 11, 2017	K162977	ADVIA 2120i, ADVIA 2120	GKZ	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 9, 2017	K161954	Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)	JGS	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
December 11, 2015	K151767	Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator	JGS	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
November 20, 2015	K151792	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 22, 2015	K141999	ADVIA CENTAUR TSH	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
November 23, 2011	K102644	ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I	GKZ	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
July 2, 2004	K041133	MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	CDD	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
September 9, 2003	K032525	BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	NBC	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
September 21, 2001	K012904	ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION	GKZ	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
February 5, 2001	K003796	ADVIA 120 HEMATOLOGY	GKZ	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
August 29, 1997	K971998	ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM	GKL	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov

Compare with other makers

Updated July 13, 2023. 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.