INSTRUMENTATION LABORATORY CO.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1217183	1217183	INSTRUMENTATION LABORATORY CO.	1	N	2026-01-01	180 Hartwell Rd. Bedford MA US 01730
2431530	2431530	INSTRUMENTATION LABORATORY CO.	1	Y	2026-01-01	526 Route 303 ORANGEBURG NY US 10962
3012775350	3012775350	Instrumentation Laboratory Co.	1	Y	2020-04-25	18B Independence Dr Devens MA US 01434

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
29966	1772099938	K992834	GEM PREMIER 3000	CHL	1999-11-24
197836	1772099938	K992834	GEM PREMIER 3000	CHL	1999-11-24
29960	1885556154	K992704	IL TEST VON WILLEBRAND FACTOR	GGP	1999-11-01
197836	1885556154	K992704	IL TEST VON WILLEBRAND FACTOR	GGP	1999-11-01
29960	1401783295	K992531	ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM	JOZ	1999-12-20
29960	1271017991	K990449	HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE	JPA	1999-04-13
29960	1496326083	K983475	HEMOCHRON RESPONSE	KQG	1999-05-03
29966	1312297936	K983178	COAMATIC HEPARIN	KFF	1998-11-03
29966	1149139197	K981696	IL TEST PLASMIN INHIBITOR	GGP	1998-08-27
197836	1149139197	K981696	IL TEST PLASMIN INHIBITOR	GGP	1998-08-27
29966	1081003293	K981200	IL TEST PLASMINOGEN	GGP	1998-05-26
197836	1081003293	K981200	IL TEST PLASMINOGEN	GGP	1998-05-26
29966	1777208646	K981038	COAMATIC FACTOR VIII	GGP	1998-04-16
29966	1968806649	K980242	IL TEST HEPARIN	KFF	1998-03-19
197836	1968806649	K980242	IL TEST HEPARIN	KFF	1998-03-19
29966	1894707789	K973306	IL TEST APTT-SP	GFO	1997-11-04
197836	1894707789	K973306	IL TEST APTT-SP	GFO	1997-11-04
29960	1946200015	K972866	HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT	GJS	1998-09-30
29960	1800955778	K972831	HEMOCHRON CITRATE APTT	GFO	1997-11-20
29966	1895954946	K963902	QUANTITATIVE FIBRINOGEN ASSAY	GIS	1996-11-29
197836	1895954946	K963902	QUANTITATIVE FIBRINOGEN ASSAY	GIS	1996-11-29
29966	1832492369	K963111	COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S	GGW	1996-12-23
197836	1832492369	K963111	COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S	GGW	1996-12-23
29960	1403472116	K961991	ACL 6000 SYSTEM (ACL 6000)	GKP	1996-09-04
29960	1656766759	K960749	HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT	JBP	1996-08-12
29966	1681254823	K955638	SYNTHAFAX APTT REAGENT	GFO	1996-04-23
29960	1095726868	K951485	AVOXIMETER 4000	JKS	1995-11-06
29966	1824544598	K945940	COATEST(R) APC(TM) RESISTANCE	GGW	1995-08-07
29960	1536383987	K944691	ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II	GGN	1995-03-15
29960	1292766525	K941007	CATALOG NO. J-ACT+ & QC-ACT+	JBP	1994-06-30
29960	1426950604	K940432	MICROCOAGULATION PROTHROMBIN TIME TEST	GJS	1994-05-18
29960	1800289689	K940401	JR. MICROCOAGULATION SYSTEM	JPA	1994-05-11
29966	1179657055	K931721	IL TEST FIBRINOGEN-C	KQJ	1993-08-13
197836	1179657055	K931721	IL TEST FIBRINOGEN-C	KQJ	1993-08-13
29960	1220629430	K923302	TENDERLETT FINGER	FMK	1993-01-22
29966	1115167536	K922201	COAMATE PROTEIN C CHROMOGENIC ASSAY	GGP	1992-12-07
29960	1140661526	K922075	AVOXIMETER	DQA	1992-11-04
29960	1870179862	K913861	HEMOCHRON(R) KACT	JBP	1991-10-18
29960	1819604695	K910105	PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200	GFT	1991-02-26
29960	1560395291	K904003	HEMOCHRON(R) HEPARIN RESPONSE TEST	KFF	1990-11-29
29960	2021461086	K882481	HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II	GGN	1988-08-30
29960	1509976125	K870831	PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA	JPA	1987-06-01
29966	1262449478	K862301	IL SYSTEM 810, ACL AND THE REAGENT SETS	GJA	1986-09-03
197836	1262449478	K862301	IL SYSTEM 810, ACL AND THE REAGENT SETS	GJA	1986-09-03
29960	1279147796	K850542	SURGICUTT - BLEEDING TIME DEVICE	JCA	1985-03-01
29966	1557752371	K833891	COATEST HEPARIN	KFF	1984-01-30
29966	1609737178	K823480	IL 943 FLAME PHOTOMETER	JJO	1983-01-09
29960	1337402994	K251968	HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL	KQJ	2025-07-24
29966	1337402994	K251968	HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL	KQJ	2025-07-24
29960	1057043269	K243374	HemosIL CL HIT-IgG(PF4-H)	LCO	2025-01-28
29960	1538470184	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	2024-08-16
29960	1204385345	K233790	ACL TOP 970 CL	JPA	2023-12-29
29960	1097462032	K231031	ACL TOP Family 70 Series	GKP	2023-06-21
29966	1219629958	K230852	HemosIL Chromogenic Factor IX	GGP	2023-12-13
29960	1219629958	K230852	HemosIL Chromogenic Factor IX	GGP	2023-12-13
29960	1221365479	K223608	GEM Premier 7000 with IQM3	CHL	2023-08-10
29966	1221365479	K223608	GEM Premier 7000 with IQM3	CHL	2023-08-10
29966	1767613970	K223402	HemosIL von Willebrand Factor Antigen	GGP	2022-12-09
29960	1113469663	K223352	Tenderfoot	FMK	2023-03-02
29966	1756489496	K223187	HemosIL Liquid Anti-Xa	QLU	2023-06-23
29960	2005030809	K223090	GEM Premier ChemSTAT	CGA	2023-01-27
29966	2005030809	K223090	GEM Premier ChemSTAT	CGA	2023-01-27
29960	1365523484	K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM	JPA	2023-09-29
29966	1304720626	K213464	HemosIL Liquid Anti-Xa	KFF	2022-10-04
29966	1281073832	K213426	HemosIL ReadiPlasTin	GJS	2022-08-16
29960	1383157524	K203790	GEM Premier 5000	CHL	2021-08-20
29966	1383157524	K203790	GEM Premier 5000	CHL	2021-08-20
29960	1336453247	K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2	JPA	2021-12-29
29960	1639973879	K201440	ROTEM sigma Thromboelastometry System	JPA	2022-07-08
29960	1527594429	K200033	HemosIL von Willebrand Factor Antigen	GGP	2020-08-19
29960	1758483891	K193041	Hemochron Signature Elite	JPA	2019-11-22
29960	1590572995	K183555	GEM Premier ChemSTAT	JFY	2019-02-16
29960	1552098186	K183549	GEM Premier ChemSTAT	JGS	2019-02-16
197836	1552098186	K183549	GEM Premier ChemSTAT	JGS	2019-02-16
197836	1926549227	K183546	GEM Premier ChemSTAT	CGA	2019-02-16
29960	1926549227	K183546	GEM Premier ChemSTAT	CGA	2019-02-16
29966	1729456777	K180486	HemosIL Factor XII Deficient Plasma	GJT	2018-03-22
197836	1729456777	K180486	HemosIL Factor XII Deficient Plasma	GJT	2018-03-22
29960	1950648042	K173403	GEM Premier 5000	CHL	2017-12-29
197836	1950648042	K173403	GEM Premier 5000	CHL	2017-12-29
29960	1488080620	K172903	HemosIL D-Dimer HS 500	DAP	2017-11-22
197836	1488080620	K172903	HemosIL D-Dimer HS 500	DAP	2017-11-22
29960	1807370678	K170854	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls	LCO	2017-09-08
29960	1058230557	K170314	ACL AcuStar	JPA	2017-03-03
197836	1058230557	K170314	ACL AcuStar	JPA	2017-03-03
29960	1579474178	K161818	GEM Premier 3000	CGA	2016-09-14
197836	1579474178	K161818	GEM Premier 3000	CGA	2016-09-14
29960	1020253723	K160885	HemosIL D-Dimer HS	DAP	2016-10-27
29966	1822229118	K160445	HemosIL Silica Clotting Time	GFO	2016-03-16
197836	1822229118	K160445	HemosIL Silica Clotting Time	GFO	2016-03-16
29960	1051065226	K160415	GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)	GKF	2016-12-14
29960	1864171091	K160412	GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)	CHL	2016-12-14
29960	1895356258	K160402	GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)	CGA	2016-12-14
29960	1339680759	K160276	ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)	GKP	2016-03-03
197836	1339680759	K160276	ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)	GKP	2016-03-03
29966	1527959405	K160225	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator	JGS	2016-12-14
197836	1527959405	K160225	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator	JGS	2016-12-14
29960	1902345023	K153137	HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls	LCO	2016-07-08
29960	1729930810	K152875	QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls	MSV	2015-12-21
29960	1139749572	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	2015-12-13
197836	1139749572	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	2015-12-13
29960	1086341603	K141427	ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST	JOZ	2015-07-24
29960	1144004956	K133582	HEMOSIL D-DIMER HS 500 CONTROL	GGN	2014-08-15
29966	1179785796	K133407	GEM PREMIER 4000	CHL	2014-01-13
29960	1179785796	K133407	GEM PREMIER 4000	CHL	2014-01-13
29966	2033516696	K132722	HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)	GJS	2014-01-22
197836	2033516696	K132722	HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)	GJS	2014-01-22
29966	1622869198	K122584	HEMOSIL READIPLAS TIN	GJS	2013-03-24
197836	1622869198	K122584	HEMOSIL READIPLAS TIN	GJS	2013-03-24
29960	1300202113	K120977	DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC	GGN	2013-07-03
29966	1507793762	K113211	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	GGN	2012-01-04
197836	1507793762	K113211	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	GGN	2012-01-04
29960	1235281195	K112995	GEM PREMIER 4000	CEM	2012-05-03
29966	1235281195	K112995	GEM PREMIER 4000	CEM	2012-05-03
197836	1235281195	K112995	GEM PREMIER 4000	CEM	2012-05-03
29966	1649232801	K110237	HEMOSIL FACTOR VIII DEFICIENT PLASMA	GJT	2011-07-08
197836	1649232801	K110237	HEMOSIL FACTOR VIII DEFICIENT PLASMA	GJT	2011-07-08
29966	1973162249	K110031	HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM	GIR	2011-08-24
197836	1973162249	K110031	HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM	GIR	2011-08-24
29966	1130355042	K102164	HEMOSIL PROTEIN S ACTIVITY ASSAY	GGP	2011-03-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GGP	22	2023-12-13
JPA	20	2023-12-29
GJT	19	2018-03-22
GGN	16	2014-08-15
CHL	11	2023-08-10
CGA	11	2023-01-27
GJS	11	2022-08-16
DAP	11	2017-11-22
KFF	9	2022-10-04
GFO	8	2016-03-16
GKP	7	2024-08-16
KQJ	6	2025-07-24
JOZ	6	2015-07-24
JGS	4	2019-02-16
JBQ	4	2007-02-23
LCO	3	2025-01-28
MSV	3	2015-12-21
CEM	3	2012-05-03
GGW	3	1996-12-23
JBP	3	1996-08-12
QLU	2	2023-06-23
FMK	2	2023-03-02
GIR	2	2011-08-24
MID	2	2010-03-11
LPS	2	2006-09-22
JIX	2	2004-09-28
GIS	2	1996-11-29
GJA	2	1986-09-03
JFY	1	2019-02-16
GKF	1	2016-12-14
CIG	1	2010-06-18
NZB	1	2010-05-04
JIS	1	2003-06-06
KQG	1	1999-05-03
JKS	1	1995-11-06
DQA	1	1992-11-04
GFT	1	1991-02-26
JCA	1	1985-03-01
JJO	1	1983-01-09

PMN#

HemosIL Von Willebrand Factor Antigen
2022-12-09
Instrumentation Laboratory Co.
GEM Premier 5000
2021-08-20
Instrumentation Laboratory Co.
HemosIL Von Willebrand Factor Antigen
2020-08-19
Instrumentation Laboratory Co.
GEM Premier ChemSTAT
2019-02-16
Instrumentation Laboratory Co.
GEM Premier ChemSTAT
2019-02-16
Instrumentation Laboratory Co.
GEM Premier ChemSTAT
2019-02-16
Instrumentation Laboratory Co.
HemosIL Factor XII Deficient Plasma
2018-03-22
Instrumentation Laboratory Co.
GEM Premier 5000
2017-12-29
Instrumentation Laboratory Co.
HemosIL D-Dimer HS 500
2017-11-22
Instrumentation Laboratory Co.
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
2017-09-08
Instrumentation Laboratory Co.
ACL AcuStar
2017-03-03
INSTRUMENTATION LABORATORY CO.
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 TBili, GEM System Evaluator, GEM Hematocrit Evaluator
2016-12-14
INSTRUMENTATION LABORATORY CO.
GEM Premier 5000 (Measured Parameters:Glucose, Lactate And Total Bilirubin)
2016-12-14
Instrumentation Laboratory Co.
GEM Premier 5000 (Measured Parameters: PH, PCO2 And PO2)
2016-12-14
Instrumentation Laboratory Co.
GEM Premier 5000 (Measured Parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
2016-12-14
Instrumentation Laboratory Co.
HemosIL D-Dimer HS
2016-10-27
INSTRUMENTATION LABORATORY CO.
GEM Premier 3000
2016-09-14
Instrumentation Laboratory Co.
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
2016-07-08
INSTRUMENTATION LABORATORY CO.
HemosIL Silica Clotting Time
2016-03-16
INSTRUMENTATION LABORATORY CO.
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
2016-03-03
INSTRUMENTATION LABORATORY CO.
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
2015-12-13
Instrumentation Laboratory Co.
HemosIL D-Dimer HS
2015-07-06
INSTRUMENTATION LABORATORY CO.
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
2014-03-13
INSTRUMENTATION LABORATORY CO.
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
2014-01-22
INSTRUMENTATION LABORATORY CO.
GEM PREMIER 4000
2014-01-13
INSTRUMENTATION LABORATORY CO.
HEMOSIL READIPLAS TIN
2013-03-24
INSTRUMENTATION LABORATORY CO.
GEM PREMIER 4000
2012-05-03
INSTRUMENTATION LABORATORY CO.
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
2012-01-04
INSTRUMENTATION LABORATORY CO.
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
2011-08-24
INSTRUMENTATION LABORATORY CO.
HEMOSIL FACTOR VIII DEFICIENT PLASMA
2011-07-08
INSTRUMENTATION LABORATORY CO.
HEMOSIL LA POSITIVE CONTROL
2011-04-05
INSTRUMENTATION LABORATORY CO.
HEMOSIL PROTEIN S ACTIVITY ASSAY
2011-03-17
INSTRUMENTATION LABORATORY CO.
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
2010-06-18
INSTRUMENTATION LABORATORY CO.
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
2010-05-21
INSTRUMENTATION LABORATORY CO.
HEMOSIL F11 & FV DNA CONTROL
2010-05-04
INSTRUMENTATION LABORATORY CO.
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
2010-03-11
INSTRUMENTATION LABORATORY CO.
HEMOSIL D-DIMER HS 500, CONTROLS
2010-02-05
INSTRUMENTATION LABORATORY CO.
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
2009-10-09
INSTRUMENTATION LABORATORY CO.
ACL TOP 700 LAS
2009-09-22
INSTRUMENTATION LABORATORY CO.
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
2009-06-02
INSTRUMENTATION LABORATORY CO.

200 records. Showing 1-40. Next