FDA.reportPublic FDA data

INSTRUMENTATION LABORATORY CO. - Devens

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30370006373037000637INSTRUMENTATION LABORATORY CO. - Devens1Y2026-01-0111 Grant Road Devens MA US 01434

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3376461772099938K992834GEM PREMIER 3000CHL1999-11-24
3376461312297936K983178COAMATIC HEPARINKFF1998-11-03
3376461149139197K981696IL TEST PLASMIN INHIBITORGGP1998-08-27
3376461081003293K981200IL TEST PLASMINOGENGGP1998-05-26
3376461777208646K981038COAMATIC FACTOR VIIIGGP1998-04-16
3376461968806649K980242IL TEST HEPARINKFF1998-03-19
3376461895954946K963902QUANTITATIVE FIBRINOGEN ASSAYGIS1996-11-29
3376461832492369K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SGGW1996-12-23
3376461681254823K955638SYNTHAFAX APTT REAGENTGFO1996-04-23
3376461824544598K945940COATEST(R) APC(TM) RESISTANCEGGW1995-08-07
3376461179657055K931721IL TEST FIBRINOGEN-CKQJ1993-08-13
3376461115167536K922201COAMATE PROTEIN C CHROMOGENIC ASSAYGGP1992-12-07
3376461262449478K862301IL SYSTEM 810, ACL AND THE REAGENT SETSGJA1986-09-03
3376461557752371K833891COATEST HEPARINKFF1984-01-30
3376461337402994K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ2025-07-24
3376461057043269K243374HemosIL CL HIT-IgG(PF4-H)LCO2025-01-28
3376461538470184K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)GKP2024-08-16
3376461204385345K233790ACL TOP 970 CLJPA2023-12-29
3376461097462032K231031ACL TOP Family 70 SeriesGKP2023-06-21
3376461219629958K230852HemosIL Chromogenic Factor IXGGP2023-12-13
3376461221365479K223608GEM Premier 7000 with IQM3CHL2023-08-10
3376461767613970K223402HemosIL von Willebrand Factor AntigenGGP2022-12-09
3376461756489496K223187HemosIL Liquid Anti-XaQLU2023-06-23
3376462005030809K223090GEM Premier ChemSTATCGA2023-01-27
3376461365523484K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA2023-09-29
3376461304720626K213464HemosIL Liquid Anti-XaKFF2022-10-04
3376461281073832K213426HemosIL ReadiPlasTinGJS2022-08-16
3376461383157524K203790GEM Premier 5000CHL2021-08-20
3376461639973879K201440ROTEM sigma Thromboelastometry SystemJPA2022-07-08
3376461527594429K200033HemosIL von Willebrand Factor AntigenGGP2020-08-19
3376461729456777K180486HemosIL Factor XII Deficient PlasmaGJT2018-03-22
3376461950648042K173403GEM Premier 5000CHL2017-12-29
3376461488080620K172903HemosIL D-Dimer HS 500DAP2017-11-22
3376461807370678K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO2017-09-08
3376461579474178K161818GEM Premier 3000CGA2016-09-14
3376461020253723K160885HemosIL D-Dimer HSDAP2016-10-27
3376461822229118K160445HemosIL Silica Clotting TimeGFO2016-03-16
3376461051065226K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)GKF2016-12-14
3376461864171091K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)CHL2016-12-14
3376461895356258K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)CGA2016-12-14
3376461339680759K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)GKP2016-03-03
3376461527959405K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorJGS2016-12-14
3376461902345023K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCO2016-07-08
3376461729930810K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsMSV2015-12-21
3376461139749572K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LASGKP2015-12-13
3376461144004956K133582HEMOSIL D-DIMER HS 500 CONTROLGGN2014-08-15
3376461179785796K133407GEM PREMIER 4000CHL2014-01-13
3376462033516696K132722HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)GJS2014-01-22
3376461507793762K113211HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROLGGN2012-01-04
3376461235281195K112995GEM PREMIER 4000CEM2012-05-03
3376461649232801K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAGJT2011-07-08
3376461973162249K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMGIR2011-08-24
3376461130355042K102164HEMOSIL PROTEIN S ACTIVITY ASSAYGGP2011-03-17
3376461325706031K101533EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEMJPA2011-08-10
3376461968171598K092181HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLSMID2010-03-11
3376461891020754K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSMSV2010-05-21
3376461208634087K090563HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)GGN2009-10-09
3376461257016679K090264HEMOSIL D-DIMER HS 500, CONTROLSDAP2010-02-05
3376461291679161K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSKFF2009-06-02
3376461485479056K083842ROTEM DELTA THROMBOELASTOMETRY SYSTEMJPA2010-03-23
3376461125474221K083518ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLSJPA2009-03-13
3376461020664099K082859HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYEDGGN2008-12-19
3376461279057002K073367HEMOSIL FIBRINOGEN-CKQJ2007-12-27
3376461369788563K073042HEMOSIL D-DIMERDAP2008-07-31
3376461217137500K070635HEMOSIL PROCLOTGGP2007-03-29
3376461978860995K070005HEMOSIL RECOMBIPLASTIN 2GGJS2007-08-15
3376461281816511K062431HEMOSIL LIQUID ANTITHROMBINJBQ2006-09-01
3376461079138020K062430HEMOSIL PROTEIN CGGP2006-09-01
3376461232269286K061598HEMOSIL HOMOCYSTEINE AND CONTROLSLPS2006-09-22
3376461646316506K060931HEMOSIL PT-FIBRINOGEN HS PLUSGJS2006-05-02
3376461065645381K060688HEMOSIL SYNTHASILGFO2006-04-13
3376461100666858K060162ACL ELITE; ACL ELITE PROJPA2006-02-21
3376461313737579K052121GEM PREMIER 3000CGA2005-10-21
3376461216649757K050544HEMOSIL D-DIMER HSDAP2005-04-26
3376461902703654K042576COATEST SP FVIIIGGP2004-12-02
3376461278144290K041905HEMOSIL CALIBRATION PLASMAJIX2004-09-28
3376461060896307K040843HEMOSIL VON WILLEBRAND ACTIVITYGGP2004-04-30
3376461769168088K040359HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2JPA2004-03-19
3376462061948190K034007HEMOSIL FACTOR VIII DEFICIENT PLASMAGJT2004-02-13
3376461827304649K031829HEMOSIL FACTOR IX DEFICIENT PLASMAGJT2003-07-31
3376461990822725K031122HEMOSIL FACTOR X DEFICIENT PLASMAGJT2003-05-19
3376461353313424K030964CALIBRATION PLASMA LMW HEPARINJIS2003-06-06
3376461723744920K030287HEMOSIL FACTOR XI DEFICIENT PLASMAGJT2003-03-19
3376461164788328K024082HEMOSIL FACTOR VII DEFICIENT PLASMAGJT2003-02-12
3376461730304804K023839HEMOSIL FACTOR V DEFICIENT PLASMAGJT2003-01-14
3376461369019933K021024HEMOSIL HIGH ABNORMAL CONTROL ASSAYEDGGN2002-05-16
3376461496420459K021023HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)GGN2002-05-14
3376461891250653K021022HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)GGN2002-05-14
3376461180166449K010520GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERSCGA2001-05-07
3376462016613135K010379IL TEST FREE PROTEIN SGGP2001-04-13
3376461810551715DEN190032HemosIL Liquid Anti-XaQLU2020-09-17
3376461217055928
3376461265043541
3376461325080518
3376461392639118
3376461545257468
3376461583157511
3376461600683878
3376461611235599
3376461639467370
3376461671050146
3376461690336043
3376461853390600
3376461901319535
3376462059628939

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GGP132023-12-13
JPA82023-12-29
GJT82018-03-22
GGN72014-08-15
CHL62023-08-10
CGA52023-01-27
KFF52022-10-04
DAP52017-11-22
GKP42024-08-16
GJS42022-08-16
KQJ32025-07-24
LCO32025-01-28
GFO32016-03-16
QLU22023-06-23
MSV22015-12-21
GGW21996-12-23
JGS12016-12-14
GKF12016-12-14
CEM12012-05-03
GIR12011-08-24
MID12010-03-11
LPS12006-09-22
JBQ12006-09-01
JIX12004-09-28
JIS12003-06-06
GIS11996-11-29
GJA11986-09-03