Data / Medical devices / United States / INSTRUMENTATION LABORATORY CO. - Devens

INSTRUMENTATION LABORATORY CO. - Devens: FDA-registered device maker in Devens, MA, United States, 91 510(k) clearances

Name: INSTRUMENTATION LABORATORY CO. - Devens FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

INSTRUMENTATION LABORATORY CO. - Devens is registered with the FDA (registration 3037000637) in Devens, MA, United States. It lists 53 device types. The FDA files 91 510(k) clearances under its listings, the newest dated July 24, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3037000637
Address: 11 Grant Road, Devens, MA, United States, 01434
Owner or operator: Instrumentation Laboratory Co. (1217183)
Roles: Manufacturer for export, Repackager or relabeler
First device listed: September 20, 2005
Registered through: 2026
Brand names listed: ACL ELITE, ACL ELITE (Refurb), ACL ELITE PRO, ACL ELITE Pro (Refurb), ACL TOP 300 CTS, ACL TOP 300 CTS (Refurb), ACL TOP 350 CTS, ACL TOP 500 CTS and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Repackager or relabeler	accessdata.fda.gov
Activated Partial Thromboplastin	GFO	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Repackager or relabeler	accessdata.fda.gov
Anti-Factor Xa Activity Test System, Apixaban	QLU	2	Repackager or relabeler	accessdata.fda.gov
Antiserum, Positive Control, Aspergillus Spp.	KFG	1	Repackager or relabeler	accessdata.fda.gov
Antithrombin Iii Quantitation	JBQ	2	Repackager or relabeler	accessdata.fda.gov
Assay, Carboxyhemoglobin	GHS	2	Repackager or relabeler	accessdata.fda.gov
Assay, Heparin	KFF	2	Repackager or relabeler	accessdata.fda.gov
Assay, Oral Direct Thrombin Inhibitor	QBG	N	Manufacturer for export	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Repackager or relabeler	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Repackager or relabeler	accessdata.fda.gov
Calibrator, Primary	JIS	2	Repackager or relabeler	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Repackager or relabeler	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Control, Hematocrit	GLK	2	Repackager or relabeler	accessdata.fda.gov
Control, Plasma, Abnormal	GGC	2	Repackager or relabeler	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Repackager or relabeler	accessdata.fda.gov
Drug Specific Control Materials	LAS	1	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Repackager or relabeler	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Repackager or relabeler	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Repackager or relabeler	accessdata.fda.gov
Factor Xiii A, S, Antigen, Antiserum, Control	DBT	1	Repackager or relabeler	accessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	2	Repackager or relabeler	accessdata.fda.gov
Fluorometric, Calcium	JFO	2	Repackager or relabeler	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Coagulation, Automated	GKP	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Hematocrit, Automated	GKF	2	Repackager or relabeler	accessdata.fda.gov
Medical Device Data System	OUG	1	Repackager or relabeler	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Repackager or relabeler	accessdata.fda.gov
Oximeter To Measure Hemoglobin	GLY	2	Repackager or relabeler	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Plasma, Coagulation Factor Deficient	GJT	2	Repackager or relabeler	accessdata.fda.gov
Plasma, Control, Normal	GIZ	2	Repackager or relabeler	accessdata.fda.gov
Platelet Factor 4 Radioimmunoassay	LCO	2	Repackager or relabeler	accessdata.fda.gov
Reagent, Russel Viper Venom	GIR	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
System, Fibrinogen Determination	KQJ	2	Repackager or relabeler	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Repackager or relabeler	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Repackager or relabeler	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Repackager or relabeler	accessdata.fda.gov
Test, Fibrinogen	GIS	2	Repackager or relabeler	accessdata.fda.gov
Test, Qualitative And Quantitative Factor Deficiency	GGP	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Thrombin Time	GJA	2	Repackager or relabeler	accessdata.fda.gov
Test, Time, Partial Thromboplastin	GGW	2	Repackager or relabeler	accessdata.fda.gov
Test, Time, Prothrombin	GJS	2	Repackager or relabeler	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Repackager or relabeler	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Repackager or relabeler	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 24, 2025	K251968	HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL	KQJ	Substantially Equivalent	Instrumentation Laboratory (IL) Co.	accessdata.fda.gov
January 28, 2025	K243374	HemosIL CL HIT-IgG(PF4-H)	LCO	Substantially Equivalent	Instrumentation Laboratory (IL) Co.	accessdata.fda.gov
August 16, 2024	K242127	ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)	GKP	Substantially Equivalent	Instrumentation Laboratory (IL) Co.	accessdata.fda.gov
December 29, 2023	K233790	ACL TOP 970 CL	JPA	Substantially Equivalent	Instrumentation Laboratory	accessdata.fda.gov
December 13, 2023	K230852	HemosIL Chromogenic Factor IX	GGP	Substantially Equivalent	Instrumentation Laboratory Company	accessdata.fda.gov
September 29, 2023	K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM	JPA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 10, 2023	K223608	GEM Premier 7000 with IQM3	CHL	Substantially Equivalent	Instrumentation Laboratory Company	accessdata.fda.gov
June 23, 2023	K223187	HemosIL Liquid Anti-Xa	QLU	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
June 21, 2023	K231031	ACL TOP Family 70 Series	GKP	Substantially Equivalent	Instrumentation Laboratory Company	accessdata.fda.gov
January 27, 2023	K223090	GEM Premier ChemSTAT	CGA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 9, 2022	K223402	HemosIL von Willebrand Factor Antigen	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
October 4, 2022	K213464	HemosIL Liquid Anti-Xa	KFF	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 16, 2022	K213426	HemosIL ReadiPlasTin	GJS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
July 8, 2022	K201440	ROTEM sigma Thromboelastometry System	JPA	Substantially Equivalent	Tem Innovations GmbH	accessdata.fda.gov
August 20, 2021	K203790	GEM Premier 5000	CHL	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 17, 2020	DEN190032	HemosIL Liquid Anti-Xa	QLU	Unknown	Instrumentation Laboratory CO	accessdata.fda.gov
August 19, 2020	K200033	HemosIL von Willebrand Factor Antigen	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 22, 2018	K180486	HemosIL Factor XII Deficient Plasma	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 29, 2017	K173403	GEM Premier 5000	CHL	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
November 22, 2017	K172903	HemosIL D-Dimer HS 500	DAP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 8, 2017	K170854	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls	LCO	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 14, 2016	K160415	GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)	GKF	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 14, 2016	K160412	GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)	CHL	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 14, 2016	K160402	GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)	CGA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 14, 2016	K160225	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator	JGS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
October 27, 2016	K160885	HemosIL D-Dimer HS	DAP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 14, 2016	K161818	GEM Premier 3000	CGA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
July 8, 2016	K153137	HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls	LCO	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 16, 2016	K160445	HemosIL Silica Clotting Time	GFO	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 3, 2016	K160276	ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)	GKP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 21, 2015	K152875	QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 13, 2015	K150877	ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS	GKP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 15, 2014	K133582	HEMOSIL D-DIMER HS 500 CONTROL	GGN	Substantially Equivalent	Instrumentation Laboratory	accessdata.fda.gov
January 22, 2014	K132722	HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)	GJS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
January 13, 2014	K133407	GEM PREMIER 4000	CHL	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 3, 2012	K112995	GEM PREMIER 4000	CEM	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
January 4, 2012	K113211	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 24, 2011	K110031	HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM	GIR	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 10, 2011	K101533	EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM	JPA	Substantially Equivalent	Tem Innovations GmbH	accessdata.fda.gov
July 8, 2011	K110237	HEMOSIL FACTOR VIII DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 17, 2011	K102164	HEMOSIL PROTEIN S ACTIVITY ASSAY	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 21, 2010	K091556	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	MSV	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 23, 2010	K083842	ROTEM DELTA THROMBOELASTOMETRY SYSTEM	JPA	Substantially Equivalent	Pentapharm GmbH	accessdata.fda.gov
March 11, 2010	K092181	HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS	MID	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 5, 2010	K090264	HEMOSIL D-DIMER HS 500, CONTROLS	DAP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
October 9, 2009	K090563	HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
June 2, 2009	K090209	HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS	KFF	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 13, 2009	K083518	ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS	JPA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 19, 2008	K082859	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
July 31, 2008	K073042	HEMOSIL D-DIMER	DAP	Substantially Equivalent	Instrumentation Laboratory	accessdata.fda.gov
December 27, 2007	K073367	HEMOSIL FIBRINOGEN-C	KQJ	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 15, 2007	K070005	HEMOSIL RECOMBIPLASTIN 2G	GJS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 29, 2007	K070635	HEMOSIL PROCLOT	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 22, 2006	K061598	HEMOSIL HOMOCYSTEINE AND CONTROLS	LPS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 1, 2006	K062431	HEMOSIL LIQUID ANTITHROMBIN	JBQ	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 1, 2006	K062430	HEMOSIL PROTEIN C	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 2, 2006	K060931	HEMOSIL PT-FIBRINOGEN HS PLUS	GJS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
April 13, 2006	K060688	HEMOSIL SYNTHASIL	GFO	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 21, 2006	K060162	ACL ELITE; ACL ELITE PRO	JPA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
October 21, 2005	K052121	GEM PREMIER 3000	CGA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
April 26, 2005	K050544	HEMOSIL D-DIMER HS	DAP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 2, 2004	K042576	COATEST SP FVIII	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
September 28, 2004	K041905	HEMOSIL CALIBRATION PLASMA	JIX	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
April 30, 2004	K040843	HEMOSIL VON WILLEBRAND ACTIVITY	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 19, 2004	K040359	HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2	JPA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 13, 2004	K034007	HEMOSIL FACTOR VIII DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
July 31, 2003	K031829	HEMOSIL FACTOR IX DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
June 6, 2003	K030964	CALIBRATION PLASMA LMW HEPARIN	JIS	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 19, 2003	K031122	HEMOSIL FACTOR X DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 19, 2003	K030287	HEMOSIL FACTOR XI DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 12, 2003	K024082	HEMOSIL FACTOR VII DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
January 14, 2003	K023839	HEMOSIL FACTOR V DEFICIENT PLASMA	GJT	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 16, 2002	K021024	HEMOSIL HIGH ABNORMAL CONTROL ASSAYED	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 14, 2002	K021023	HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 14, 2002	K021022	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	GGN	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 7, 2001	K010520	GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS	CGA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
April 13, 2001	K010379	IL TEST FREE PROTEIN S	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
November 24, 1999	K992834	GEM PREMIER 3000	CHL	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
November 3, 1998	K983178	COAMATIC HEPARIN	KFF	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
August 27, 1998	K981696	IL TEST PLASMIN INHIBITOR	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
May 26, 1998	K981200	IL TEST PLASMINOGEN	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
April 16, 1998	K981038	COAMATIC FACTOR VIII	GGP	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 19, 1998	K980242	IL TEST HEPARIN	KFF	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 23, 1996	K963111	COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S	GGW	Substantially Equivalent	Chromogenix AB	accessdata.fda.gov
November 29, 1996	K963902	QUANTITATIVE FIBRINOGEN ASSAY	GIS	Substantially Equivalent	Ortho Diagnostic Systems, Inc.	accessdata.fda.gov
April 23, 1996	K955638	SYNTHAFAX APTT REAGENT	GFO	Substantially Equivalent	Ortho Diagnostic Systems, Inc.	accessdata.fda.gov
August 7, 1995	K945940	COATEST(R) APC(TM) RESISTANCE	GGW	Substantially Equivalent	Axis-Shield Doc AS	accessdata.fda.gov
August 13, 1993	K931721	IL TEST FIBRINOGEN-C	KQJ	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
December 7, 1992	K922201	COAMATE PROTEIN C CHROMOGENIC ASSAY	GGP	Substantially Equivalent	Chromogenix AB	accessdata.fda.gov
September 3, 1986	K862301	IL SYSTEM 810, ACL AND THE REAGENT SETS	GJA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
January 30, 1984	K833891	COATEST HEPARIN	KFF	Substantially Equivalent	Kabivitrum, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 24, 2025. 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.