Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2431530

FEI Number

2431530

Entity Name

INSTRUMENTATION LABORATORY CO.

City/State/Country

ORANGEBURG, NY, US

Establishment Address

526 Route 303, ORANGEBURG, NY 10962, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Instrumentation Laboratory Co. (Owner Number: 1217183)

Owner / Operator Contact Address

180 Hartwell Road, --, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K034007

PMA Number

N/A

All Registered Proprietary Names

HemosIL Plasmin Inhibitor HemosIL Plasminogen GEM Premier ChemSTAT GEM Premier ChemSTAT PAK HemosIL Factor XI Deficient Plasma HemosIL Abnormal Control 2 HemosIL Low Abnormal Control ASSAYED HemosIL RecombiPlasTin 2G (8 mL) HemosIL Q.F.A. Thrombin (Bovine) HemosIL Fibrinogen-C HemosIL Fibrinogen-C XL HemosIL Calcium Chloride 025 M HemosIL APTT-SP HemosIL Factor V Leiden HemosIL Factor V Reagent Plasma Coatest APC Resistance V S Coatest APC Resistance V ELECTRACHROME Factor VIII Coamatic Factor VIII HemosIL dRVVT Screen HemosIL dRVVT Confirm HemosIL Dabigatran Controls HemosIL Rivaroxaban Controls HemosIL Apixaban Controls Coamatic Protein C HemosIL Factor IX Deficient Plasma GEM Crit Check ContrIL 7 1, 2, 3 and Multipak HemosIL Factor XII Deficient Plasma HemosIL PCX/HPX Thromboplastin Diluent HemosIL SynthAFax HemosIL Routine Control Level 1 HemosIL Routine Control Level 3 HemosIL Routine Control Level 2 IL Crit PVP ChemSTAT Hematocrit Evaluator 2 ChemSTAT Hematocrit Evaluator 3 ChemSTAT Hematocrit Evaluator 1 GEM ChemSTAT critPVP 1-4 GEM Hematocrit Evaluator 1 GEM Hematocrit Evaluator 2 GEM Hematocrit Evaluator 3 Coatest Heparin HemosIL Dabigatran Calibrators HemosIL Rivaroxaban Calibrators HemosIL Apixaban Calibrators HemosIL Factor VII Deficient Plasma GEM HEMATOCRIT EVALUATOR 1, 2, 3 GEM SYSTEM EVALUATOR 1, 2, 3 GEM CVP 5 tBILI HemosIL Dabigatran Calibrators HemosIL Apixaban Calibrators HemosIL Rivaroxaban Calibrators HemosIL Direct Thrombin Inhibitor Assay (0020302800) HemosIL Liquid Anti-Xa (Part No. 0020302601) HemosIL Protein C HemosIL SynthASil HemosIL Protein S Activity HemosIL Factor XII Deficient Plasma GEM Premier 5000 (Instrument) GEM Premier 5000 PAK HemosIL FII & FV DNA Control HemosIL Apixaban Controls HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL UF Heparin Controls HemosIL Liquid Anti-Xa HemosIL LMW Heparin Controls HemosIL von Willebrand Factor Antigen HemosIL Liquid Anti-Xa HemosIL Antithrombin HemosIL Thrombin Time HemosIL PT-Fibrinogen Calibration Plasma LMW Heparin HemosIL Factor V Deficient Plasma GEM CVP 2 with CO-OX (Orangeburg NY Facility) GEM CVP 3 Hematocrit (Orangeburg NY Facility) GEM CVP 1 with CO-OX (Orangeburg NY Facility) GEM CVP 5 tBili (Orangeburg NY Facility) GEM CVP 4 Hematocrit (Orangeburg NY Facility) GEM Premier 4000 PAK (Bedford MA Facility) GEM Premier 4000 (Bedford MA Facility) GEM Premier 7000 with iQM3 PAK GEM Premier 7000 with iQM3 HemosIL PT-Fibrinogen HS PLUS HemosIL Silica Clotting Time HemosIL Abnormal Control 3 HemosIL High Abnormal Control ASSAYED HemosIL Factor VIII Deficient Plasma ContrIL 9 Level 2 ContrIL 9 Multipak ContrIL 9 Level 3 ContrIL 9 Level 1 HemosIL Heparin HemosIL Special Test Control Level 2 HemosIL Special Test Control Level 1 HemosIL Apixaban Calibrators HemosIL Chromogenic Factor IX HemosIL Factor X Deficient Plasma HemosIL Plasma Coagulation Control Level 1 HemosIL Plasma Coagulation Control Level 2 HemosIL Rivaroxaban Controls HemosIL Apixaban Controls HemosIL Dabigatran Controls HemosIL Factor VIII Deficient Plasma

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-03-02
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2023-03-02
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2023-03-02
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-03-02
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2023-03-02
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-03-02
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2023-03-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-03-02
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-03-02
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2023-03-02
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2023-03-02
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-11
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2018-03-09
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2018-03-09
GJA	Test, Thrombin Time	Hematology	Class 2	864.7875	2007-11-30
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2007-11-30
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2012-11-02
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2012-11-02
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-11-30
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2011-09-20
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2011-09-20
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-09-23
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-18
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-06-03
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-06-03
JFO	Fluorometric, Calcium	Clinical Chemistry	Class 2	862.1145	2008-06-03
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-06-03
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2008-06-03
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2012-11-02
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2012-11-02
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-11-02
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2018-03-08
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2012-12-17
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-09-23
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-02-14
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2017-02-14
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2017-02-14
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-02-14
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-02-14
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2017-02-14
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2017-02-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2021-07-23
QBG	Assay, Oral Direct Thrombin Inhibitor	Unknown	Class N	N/A	2018-03-13
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-11-02
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2007-11-30
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2012-12-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2018-05-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2021-08-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2021-08-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-08-30
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2021-08-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2021-08-30
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2021-08-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2021-08-30
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2021-08-30
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2021-08-30
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2021-08-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2021-08-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2021-08-30
NZB	Quality Control Material, Genetics, Dna	Microbiology	Class 2	866.5910	2013-03-26
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2021-03-12
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-11-02
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2012-11-02
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-11-02
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2023-01-21
QLU	Anti-Factor Xa Activity Test System, Apixaban	Hematology	Class 2	864.7295	2023-07-21
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2007-10-11
GJA	Test, Thrombin Time	Hematology	Class 2	864.7875	2007-11-30
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-03
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-03
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-12-26
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2012-12-26
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2012-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-12-26
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2012-12-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-12-26
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-12-26
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2012-12-26
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2012-12-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-12-26
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2012-12-26
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2012-12-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-12-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-08-23
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2023-08-23
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2023-08-23
GHS	Assay, Carboxyhemoglobin	Hematology	Class 2	864.7425	2023-08-23
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-08-23
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2023-08-23
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-08-23
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-08-23
GLY	Oximeter To Measure Hemoglobin	Hematology	Class 2	864.7500	2023-08-23
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2023-08-23
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-08-23
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2023-08-23
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2012-11-02
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2012-11-02
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2018-03-09
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-26
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-12-26
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2012-11-02
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-11-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2021-03-12
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2024-04-11
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-12
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2012-12-11

Official Correspondent

Carol Marble

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Instrumentation Laboratory Co.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0135-2011	Instrumentation Laboratory Co.	2	ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-0136-2011	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0137-2011	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Similar Registrations

Registration Number	Establishment Name	Location
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US
1618982	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2431530. Last updated year: 2026. Please use registration number 2431530 when referencing this establishment in official correspondence.