Atlas FDA

Instrumentation Laboratory CO

321 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (K221359)Instrumentation Laboratory CO2023-09-29
HemosIL Liquid Anti-Xa (K223187)Instrumentation Laboratory CO2023-06-23
GEM Premier ChemSTAT (K223090)Instrumentation Laboratory CO2023-01-27
HemosIL von Willebrand Factor Antigen (K223402)Instrumentation Laboratory CO2022-12-09
HemosIL Liquid Anti-Xa (K213464)Instrumentation Laboratory CO2022-10-04
HemosIL ReadiPlasTin (K213426)Instrumentation Laboratory CO2022-08-16
GEM Premier 5000 (K203790)Instrumentation Laboratory CO2021-08-20
HemosIL Liquid Anti-Xa (DEN190032)Instrumentation Laboratory CO2020-09-17
HemosIL von Willebrand Factor Antigen (K200033)Instrumentation Laboratory CO2020-08-19
GEM Premier ChemSTAT (K183555)Instrumentation Laboratory CO2019-02-16
GEM Premier ChemSTAT (K183546)Instrumentation Laboratory CO2019-02-16
GEM Premier ChemSTAT (K183549)Instrumentation Laboratory CO2019-02-16
HemosIL Factor XII Deficient Plasma (K180486)Instrumentation Laboratory CO2018-03-22
GEM Premier 5000 (K173403)Instrumentation Laboratory CO2017-12-29
HemosIL D-Dimer HS 500 (K172903)Instrumentation Laboratory CO2017-11-22
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (K170854)Instrumentation Laboratory CO2017-09-08
ACL AcuStar (K170314)Instrumentation Laboratory CO2017-03-03
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) (K160412)Instrumentation Laboratory CO2016-12-14
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415)Instrumentation Laboratory CO2016-12-14
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (K160225)Instrumentation Laboratory CO2016-12-14
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) (K160402)Instrumentation Laboratory CO2016-12-14
HemosIL D-Dimer HS (K160885)Instrumentation Laboratory CO2016-10-27
GEM Premier 3000 (K161818)Instrumentation Laboratory CO2016-09-14
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137)Instrumentation Laboratory CO2016-07-08
HemosIL Silica Clotting Time (K160445)Instrumentation Laboratory CO2016-03-16
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) (K160276)Instrumentation Laboratory CO2016-03-03
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS (K150877)Instrumentation Laboratory CO2015-12-13
HemosIL D-Dimer HS (K151534)Instrumentation Laboratory CO2015-07-06
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (K133005)Instrumentation Laboratory CO2014-03-13
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) (K132722)Instrumentation Laboratory CO2014-01-22
GEM PREMIER 4000 (K133407)Instrumentation Laboratory CO2014-01-13
HEMOSIL READIPLAS TIN (K122584)Instrumentation Laboratory CO2013-03-24
GEM PREMIER 4000 (K112995)Instrumentation Laboratory CO2012-05-03
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL (K113211)Instrumentation Laboratory CO2012-01-04
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031)Instrumentation Laboratory CO2011-08-24
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237)Instrumentation Laboratory CO2011-07-08
HEMOSIL LA POSITIVE CONTROL (K102552)Instrumentation Laboratory CO2011-04-05
HEMOSIL PROTEIN S ACTIVITY ASSAY (K102164)Instrumentation Laboratory CO2011-03-17
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623)Instrumentation Laboratory CO2010-06-18
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (K091556)Instrumentation Laboratory CO2010-05-21
HEMOSIL F11 & FV DNA CONTROL (K093737)Instrumentation Laboratory CO2010-05-04
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (K092181)Instrumentation Laboratory CO2010-03-11
HEMOSIL D-DIMER HS 500, CONTROLS (K090264)Instrumentation Laboratory CO2010-02-05
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) (K090563)Instrumentation Laboratory CO2009-10-09
ACL TOP 700 LAS (K091980)Instrumentation Laboratory CO2009-09-22
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (K090209)Instrumentation Laboratory CO2009-06-02
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS (K083518)Instrumentation Laboratory CO2009-03-13
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED (K082859)Instrumentation Laboratory CO2008-12-19
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (K073377)Instrumentation Laboratory CO2008-05-04
HEMOSIL FIBRINOGEN-C (K073367)Instrumentation Laboratory CO2007-12-27
HEMOSIL D-DIMER HS (K070927)Instrumentation Laboratory CO2007-09-17
HEMOSIL RECOMBIPLASTIN 2G (K070005)Instrumentation Laboratory CO2007-08-15
HEMOSIL PROCLOT (K070635)Instrumentation Laboratory CO2007-03-29
HEMOSIL ANTITHROMBIN (K070301)Instrumentation Laboratory CO2007-02-23
ACL TOP (K063679)Instrumentation Laboratory CO2007-01-12
HEMOSIL HOMOCYSTEINE AND CONTROLS (K061598)Instrumentation Laboratory CO2006-09-22
GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT (K061974)Instrumentation Laboratory CO2006-09-15
HEMOSIL LIQUID ANTITHROMBIN (K062431)Instrumentation Laboratory CO2006-09-01
HEMOSIL PROTEIN C (K062430)Instrumentation Laboratory CO2006-09-01
HEMOSIL PT-FIBRINOGEN HS PLUS (K060931)Instrumentation Laboratory CO2006-05-02
HEMOSIL SYNTHASIL (K060688)Instrumentation Laboratory CO2006-04-13
ACL ELITE; ACL ELITE PRO (K060162)Instrumentation Laboratory CO2006-02-21
HEMOSIL PROS (K053499)Instrumentation Laboratory CO2006-01-13
GEM PREMIER 3000 (K052121)Instrumentation Laboratory CO2005-10-21
HEMOSIL FACTOR II DEFICIENT PLASMA (K050661)Instrumentation Laboratory CO2005-05-02
HEMOSIL D-DIMER HS (K050544)Instrumentation Laboratory CO2005-04-26
HEMOSIL SILICA CLOTTING TIME (K050221)Instrumentation Laboratory CO2005-03-30
HEMOSIL D-DIMER (K050278)Instrumentation Laboratory CO2005-03-10
HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459)Instrumentation Laboratory CO2005-02-09
HEMOSIL RECOMBIPLASTIN (K043184)Instrumentation Laboratory CO2004-12-22
QUANTEX MYOGLOBIN (K042982)Instrumentation Laboratory CO2004-12-22
COATEST SP FVIII (K042576)Instrumentation Laboratory CO2004-12-02
HEMOSIL CALIBRATION PLASMA (K041905)Instrumentation Laboratory CO2004-09-28
QUANTEX FERRITIN (K040879)Instrumentation Laboratory CO2004-05-10
HEMOSIL VON WILLEBRAND ACTIVITY (K040843)Instrumentation Laboratory CO2004-04-30
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 (K040359)Instrumentation Laboratory CO2004-03-19
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007)Instrumentation Laboratory CO2004-02-13
ACL TOP MODEL, TOP (K033414)Instrumentation Laboratory CO2004-01-12
HEMOSIL LIQUID ANTITHROMBIN XL (K033775)Instrumentation Laboratory CO2004-01-02
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 (K032663)Instrumentation Laboratory CO2003-12-19
MODIFICATION TO COATEST FACTOR VIII (K033631)Instrumentation Laboratory CO2003-12-15
QUANTEX D-DIMER (K032419)Instrumentation Laboratory CO2003-10-24
HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829)Instrumentation Laboratory CO2003-07-31
CONTROL PLASMA LMW HEPARIN (K030965)Instrumentation Laboratory CO2003-06-06
CALIBRATION PLASMA LMW HEPARIN (K030964)Instrumentation Laboratory CO2003-06-06
HEMOSIL FACTOR X DEFICIENT PLASMA (K031122)Instrumentation Laboratory CO2003-05-19
HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287)Instrumentation Laboratory CO2003-03-19
BIORAPID MONONUCLEOSIS (K030215)Instrumentation Laboratory CO2003-02-24
HEMOSIL FACTOR VII DEFICIENT PLASMA (K024082)Instrumentation Laboratory CO2003-02-12
HEMOSIL FACTOR V DEFICIENT PLASMA (K023839)Instrumentation Laboratory CO2003-01-14
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS (K023269)Instrumentation Laboratory CO2002-12-23
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) (K022158)Instrumentation Laboratory CO2002-09-10
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
COAMATIC AT-400 (K022195)Instrumentation Laboratory CO2002-08-07
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED (K021024)Instrumentation Laboratory CO2002-05-16
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) (K021023)Instrumentation Laboratory CO2002-05-14
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) (K021022)Instrumentation Laboratory CO2002-05-14
COLOR-MONOGEN (K012901)Instrumentation Laboratory CO2001-09-27
HEMOSIL RECOMBI PLASTIN (K012768)Instrumentation Laboratory CO2001-09-18
IL TEST PROS (K011424)Instrumentation Laboratory CO2001-06-25
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Every clearance here is in the API, with alerts when new ones post.