FDA 510(k) Applications Submitted by CAROL MARBLE

FDA 510(k) Number Submission Date Device Name Applicant
K070005 01/03/2007 HEMOSIL RECOMBIPLASTIN 2G INSTRUMENTATION LABORATORY CO.
K000053 01/07/2000 ACL 9000 SYSTEM INSTRUMENTATION LABORATORY CO.
K030215 01/21/2003 BIORAPID MONONUCLEOSIS INSTRUMENTATION LABORATORY CO.
K980242 01/23/1998 IL TEST HEPARIN INSTRUMENTATION LABORATORY CO.
K060162 01/23/2006 ACL ELITE; ACL ELITE PRO INSTRUMENTATION LABORATORY CO.
K030287 01/28/2003 HEMOSIL FACTOR XI DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K090209 01/28/2009 HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS INSTRUMENTATION LABORATORY CO.
K160225 01/29/2016 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator INSTRUMENTATION LABORATORY CO.
K050221 01/31/2005 HEMOSIL SILICA CLOTTING TIME INSTRUMENTATION LABORATORY CO.
K070301 01/31/2007 HEMOSIL ANTITHROMBIN INSTRUMENTATION LABORATORY CO.
K990302 02/01/1999 IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) INSTRUMENTATION LABORATORY CO.
K090264 02/03/2009 HEMOSIL D-DIMER HS 500, CONTROLS INSTRUMENTATION LABORATORY CO.
K050278 02/07/2005 HEMOSIL D-DIMER INSTRUMENTATION LABORATORY CO.
K010379 02/08/2001 IL TEST FREE PROTEIN S INSTRUMENTATION LABORATORY CO.
K980499 02/09/1998 IL TEST ANTITHROMBIN INSTRUMENTATION LABORATORY CO.
K160415 02/12/2016 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Instrumentation Laboratory Co.
K160412 02/12/2016 GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) Instrumentation Laboratory Co.
K040359 02/13/2004 HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 INSTRUMENTATION LABORATORY CO.
K980646 02/19/1998 IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES INSTRUMENTATION LABORATORY CO.
K180486 02/23/2018 HemosIL Factor XII Deficient Plasma Instrumentation Laboratory Co.
K980757 02/27/1998 ILAB 600 CLINICAL CHEMISTRY SYSTEM INSTRUMENTATION LABORATORY CO.
K050544 03/02/2005 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO.
K090563 03/02/2009 HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) INSTRUMENTATION LABORATORY CO.
K980875 03/06/1998 IL TEST PROTEIN C INSTRUMENTATION LABORATORY CO.
K070635 03/07/2007 HEMOSIL PROCLOT INSTRUMENTATION LABORATORY CO.
K050661 03/15/2005 HEMOSIL FACTOR II DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K060688 03/15/2006 HEMOSIL SYNTHASIL INSTRUMENTATION LABORATORY CO.
K981038 03/19/1998 COAMATIC FACTOR VIII INSTRUMENTATION LABORATORY CO.
K170854 03/22/2017 HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory Co.
K030965 03/27/2003 CONTROL PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO.
K030964 03/27/2003 CALIBRATION PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO.
K021022 03/29/2002 HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) INSTRUMENTATION LABORATORY CO.
K021024 03/29/2002 HEMOSIL HIGH ABNORMAL CONTROL ASSAYED INSTRUMENTATION LABORATORY CO.
K021023 03/29/2002 HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) INSTRUMENTATION LABORATORY CO.
K160885 03/31/2016 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO.
K040843 04/01/2004 HEMOSIL VON WILLEBRAND ACTIVITY INSTRUMENTATION LABORATORY CO.
K150877 04/01/2015 ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory Co.
K981200 04/02/1998 IL TEST PLASMINOGEN INSTRUMENTATION LABORATORY CO.
K070927 04/03/2007 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO.
K040879 04/05/2004 QUANTEX FERRITIN INSTRUMENTATION LABORATORY CO.
K060931 04/05/2006 HEMOSIL PT-FIBRINOGEN HS PLUS INSTRUMENTATION LABORATORY CO.
K981263 04/07/1998 TOXOGEN INSTRUMENTATION LABORATORY CO.
K031122 04/08/2003 HEMOSIL FACTOR X DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K231031 04/11/2023 ACL TOP Family 70 Series Instrumentation Laboratory Company
K981479 04/24/1998 IL TEST PT-FIBRINOGEN RECOMBINANT INSTRUMENTATION LABORATORY CO.
K011424 05/09/2001 IL TEST PROS INSTRUMENTATION LABORATORY CO.
K981696 05/14/1998 IL TEST PLASMIN INHIBITOR INSTRUMENTATION LABORATORY CO.
K981817 05/22/1998 COAMATIC PLASMIN INHIBITOR INSTRUMENTATION LABORATORY CO.
K091556 05/27/2009 HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS INSTRUMENTATION LABORATORY CO.
K061598 06/08/2006 HEMOSIL HOMOCYSTEINE AND CONTROLS INSTRUMENTATION LABORATORY CO.
K031829 06/13/2003 HEMOSIL FACTOR IX DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
DEN190032 06/25/2019 HemosIL Liquid Anti-Xa Instrumentation Laboratory Co.
K091980 07/01/2009 ACL TOP 700 LAS INSTRUMENTATION LABORATORY CO.
K022158 07/02/2002 IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) INSTRUMENTATION LABORATORY CO.
K022195 07/05/2002 COAMATIC AT-400 INSTRUMENTATION LABORATORY CO.
K061974 07/12/2006 GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT INSTRUMENTATION LABORATORY CO.
K041905 07/15/2004 HEMOSIL CALIBRATION PLASMA INSTRUMENTATION LABORATORY CO.
K092181 07/21/2009 HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS INSTRUMENTATION LABORATORY CO.
K022550 08/02/2002 COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS INSTRUMENTATION LABORATORY CO.
K002400 08/04/2000 MODIFICATION OF ACL ADVANCE INSTRUMENTATION LABORATORY CO.
K032419 08/05/2003 QUANTEX D-DIMER INSTRUMENTATION LABORATORY CO.
K052121 08/05/2005 GEM PREMIER 3000 INSTRUMENTATION LABORATORY CO.
K002467 08/11/2000 COALIZA PROTEIN S-FREE INSTRUMENTATION LABORATORY CO.
K992704 08/12/1999 IL TEST VON WILLEBRAND FACTOR INSTRUMENTATION LABORATORY CO.
K012768 08/17/2001 HEMOSIL RECOMBI PLASTIN INSTRUMENTATION LABORATORY CO.
K062431 08/21/2006 HEMOSIL LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO.
K062430 08/21/2006 HEMOSIL PROTEIN C INSTRUMENTATION LABORATORY CO.
K992834 08/23/1999 GEM PREMIER 3000 INSTRUMENTATION LABORATORY CO.
K032663 08/28/2003 QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 INSTRUMENTATION LABORATORY CO.
K012901 08/29/2001 COLOR-MONOGEN INSTRUMENTATION LABORATORY CO.
K973306 09/03/1997 IL TEST APTT-SP INSTRUMENTATION LABORATORY CO.
K102552 09/07/2010 HEMOSIL LA POSITIVE CONTROL INSTRUMENTATION LABORATORY CO.
K983178 09/11/1998 COAMATIC HEPARIN INSTRUMENTATION LABORATORY CO.
K973464 09/12/1997 QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) INSTRUMENTATION LABORATORY CO.
K042576 09/22/2004 COATEST SP FVIII INSTRUMENTATION LABORATORY CO.
K082859 09/29/2008 HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED INSTRUMENTATION LABORATORY CO.
K023269 10/01/2002 HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS INSTRUMENTATION LABORATORY CO.
K223187 10/12/2022 HemosIL Liquid Anti-Xa Instrumentation Laboratory Co.
K213426 10/21/2021 HemosIL ReadiPlasTin Instrumentation Laboratory Co.
K033414 10/27/2003 ACL TOP MODEL, TOP INSTRUMENTATION LABORATORY CO.
K213464 10/28/2021 HemosIL Liquid Anti-Xa Instrumentation Laboratory Co.
K042982 10/29/2004 QUANTEX MYOGLOBIN INSTRUMENTATION LABORATORY CO.
K073042 10/29/2007 HEMOSIL D-DIMER INSTRUMENTATION LABORATORY
K153137 10/30/2015 HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls INSTRUMENTATION LABORATORY CO.
K173403 10/31/2017 GEM Premier 5000 Instrumentation Laboratory Co.
K974125 11/03/1997 IL TEST AMYLASE INSTRUMENTATION LABORATORY CO.
K133407 11/06/2013 GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO.
K043184 11/17/2004 HEMOSIL RECOMBIPLASTIN INSTRUMENTATION LABORATORY CO.
K974337 11/18/1997 IL TEST UREA NITROGEN INSTRUMENTATION LABORATORY CO.
K023839 11/18/2002 HEMOSIL FACTOR V DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K033631 11/19/2003 MODIFICATION TO COATEST FACTOR VIII INSTRUMENTATION LABORATORY CO.
K133582 11/21/2013 HEMOSIL D-DIMER HS 500 CONTROL INSTRUMENTATION LABORATORY
K093623 11/23/2009 GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO INSTRUMENTATION LABORATORY CO.
K974456 11/25/1997 CMVGEN INSTRUMENTATION LABORATORY CO.
K083518 11/26/2008 ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS INSTRUMENTATION LABORATORY CO.
K073367 11/30/2007 HEMOSIL FIBRINOGEN-C INSTRUMENTATION LABORATORY CO.
K033775 12/03/2003 HEMOSIL LIQUID ANTITHROMBIN XL INSTRUMENTATION LABORATORY CO.
K073377 12/03/2007 ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) INSTRUMENTATION LABORATORY CO.
K093737 12/04/2009 HEMOSIL F11 & FV DNA CONTROL INSTRUMENTATION LABORATORY CO.
K063679 12/11/2006 ACL TOP INSTRUMENTATION LABORATORY CO.
K984437 12/14/1998 QUANTEX ASO-CRP-RP CONTROL II INSTRUMENTATION LABORATORY CO.
K043459 12/15/2004 HEMOSIL FACTOR XII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K994238 12/16/1999 IL TEST LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO.
K053499 12/16/2005 HEMOSIL PROS INSTRUMENTATION LABORATORY CO.
K034007 12/24/2003 HEMOSIL FACTOR VIII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO.
K974711 12/17/1997 COAMATIC PLASMINOGEN INSTRUMENTATION LABORATORY CO.


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