K971777 |
05/14/1997 |
QUANTEX ASO-CRP-RF CONTROL |
INSTRUMENTATION LABORATORY CO. |
K961991 |
05/21/1996 |
ACL 6000 SYSTEM (ACL 6000) |
INSTRUMENTATION LABORATORY CO. |
K962201 |
06/07/1996 |
QUANTEX IGM |
INSTRUMENTATION LABORATORY CO. |
K962202 |
06/07/1996 |
QUANTEX IGG |
INSTRUMENTATION LABORATORY CO. |
K962198 |
06/07/1996 |
QUANTEX C4 |
INSTRUMENTATION LABORATORY CO. |
K962199 |
06/07/1996 |
QUANTEX C3 |
INSTRUMENTATION LABORATORY CO. |
K962200 |
06/07/1996 |
QUANTEX IGA |
INSTRUMENTATION LABORATORY CO. |
K972363 |
06/25/1997 |
IL TEST IRON |
INSTRUMENTATION LABORATORY CO. |
K972696 |
07/18/1997 |
IL TEST D-DIMER |
INSTRUMENTATION LABORATORY CO. |
K972861 |
08/04/1997 |
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) |
INSTRUMENTATION LABORATORY CO. |
K963800 |
09/23/1996 |
IL SYNTHESIS |
INSTRUMENTATION LABORATORY CO. |
K955793 |
12/22/1995 |
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM |
INSTRUMENTATION LABORATORY CO. |
K112995 |
10/07/2011 |
GEM PREMIER 4000 |
INSTRUMENTATION LABORATORY CO. |
K024082 |
12/11/2002 |
HEMOSIL FACTOR VII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
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. |
K160412 |
02/12/2016 |
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) |
Instrumentation Laboratory Co. |
K160415 |
02/12/2016 |
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) |
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. |
K021023 |
03/29/2002 |
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) |
INSTRUMENTATION LABORATORY CO. |
K021024 |
03/29/2002 |
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED |
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. |
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. |
K062430 |
08/21/2006 |
HEMOSIL PROTEIN C |
INSTRUMENTATION LABORATORY CO. |
K062431 |
08/21/2006 |
HEMOSIL LIQUID ANTITHROMBIN |
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. |
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. |
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. |
K160402 |
02/12/2016 |
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) |
Instrumentation Laboratory Co. |
K974711 |
12/17/1997 |
COAMATIC PLASMINOGEN |
INSTRUMENTATION LABORATORY CO. |
K183546 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
K183549 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
K183555 |
12/20/2018 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
K203790 |
12/28/2020 |
GEM Premier 5000 |
Instrumentation Laboratory Co. |
K160445 |
02/17/2016 |
HemosIL Silica Clotting Time |
INSTRUMENTATION LABORATORY CO. |
K110031 |
01/05/2011 |
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM |
INSTRUMENTATION LABORATORY CO. |
K110237 |
01/26/2011 |
HEMOSIL FACTOR VIII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
K102164 |
08/02/2010 |
HEMOSIL PROTEIN S ACTIVITY ASSAY |
INSTRUMENTATION LABORATORY CO. |
K122584 |
08/24/2012 |
HEMOSIL READIPLAS TIN |
INSTRUMENTATION LABORATORY CO. |
K132722 |
08/30/2013 |
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) |
INSTRUMENTATION LABORATORY CO. |
K133005 |
09/25/2013 |
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY |
INSTRUMENTATION LABORATORY CO. |
K113211 |
10/31/2011 |
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL |
INSTRUMENTATION LABORATORY CO. |
K200033 |
01/07/2020 |
HemosIL von Willebrand Factor Antigen |
Instrumentation Laboratory Co. |
K170314 |
02/01/2017 |
ACL AcuStar |
INSTRUMENTATION LABORATORY CO. |
K160276 |
02/02/2016 |
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) |
INSTRUMENTATION LABORATORY CO. |
K221359 |
05/11/2022 |
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM |
Instrumentation Laboratory Co. |
K151534 |
06/08/2015 |
HemosIL D-Dimer HS |
INSTRUMENTATION LABORATORY CO. |
K161818 |
07/01/2016 |
GEM Premier 3000 |
Instrumentation Laboratory Co. |
K223402 |
11/09/2022 |
HemosIL von Willebrand Factor Antigen |
Instrumentation Laboratory Co. |
K010520 |
02/22/2001 |
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS |
INSTRUMENTATION LABORATORY CO. |
K172903 |
09/22/2017 |
HemosIL D-Dimer HS 500 |
Instrumentation Laboratory Co. |
K943366 |
07/13/1994 |
IL TEST ACID PHOSPHATASE |
INSTRUMENTATION LABORATORY CO. |
K943367 |
07/13/1994 |
IL TEST CHOLINESTERASE |
INSTRUMENTATION LABORATORY CO. |