FDA 510(k) Applications Submitted by ROCHE DIAGNOSTICS CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K100853 03/26/2010 COBAS 8000 MODULAR SERIES ANALYZER ROCHE DIAGNOSTICS CORP.
K051543 06/10/2005 ELECSYS PRECICONTROL BONE ROCHE DIAGNOSTICS CORP.
K060108 01/13/2006 COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 ROCHE DIAGNOSTICS CORP.
K061048 04/17/2006 COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K051185 05/09/2005 ELECSYS CA 19-9 CALCHECK ROCHE DIAGNOSTICS CORP.
K051687 06/23/2005 ELECSYS PRECICONTROL UNIVERSAL ROCHE DIAGNOSTICS CORP.
K062114 07/24/2006 CERULOPLASMIN, MODEL 2055953 ROCHE DIAGNOSTICS CORP.
K052002 07/25/2005 IRON STANDARD ROCHE DIAGNOSTICS CORP.
K062319 08/09/2006 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 ROCHE DIAGNOSTICS CORP.
K062379 08/15/2006 COBAS INTEGRA CERULOPLASMIN ROCHE DIAGNOSTICS CORP.
K063543 11/24/2006 COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 ROCHE DIAGNOSTICS CORP.
K051517 06/08/2005 ELECSYS PRECICONTROL ANEMIA ROCHE DIAGNOSTICS CORP.
K060853 03/29/2006 ONLINE TDM TOBRAMYCIN ROCHE DIAGNOSTICS CORP.
K070200 01/22/2007 TDM CONTROL SET, MODEL CAT# 04521536 ROCHE DIAGNOSTICS CORP.
K080183 01/25/2008 CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 ROCHE DIAGNOSTICS CORP.
K060429 02/21/2006 TDM CONTROL SET ROCHE DIAGNOSTICS CORP.
K060586 03/07/2006 ENZYME IMMUNOASSAY, VANCOMYCIN ROCHE DIAGNOSTICS CORP.
K060645 03/10/2006 PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS ROCHE DIAGNOSTICS CORP.
K060690 03/15/2006 ONLINE VALPROIC ACID ROCHE DIAGNOSTICS CORP.
K060738 03/20/2006 TDM N-ACETYLPROCAINAMIDE ROCHE DIAGNOSTICS CORP.
K060773 03/22/2006 ONLINE TDM PROCAINAMIDE ROCHE DIAGNOSTICS CORP.
K051592 06/15/2005 MODIFICATION TO ACCU-CHEK GO SYSTEM ROCHE DIAGNOSTICS CORP.
K071644 06/15/2007 ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 ROCHE DIAGNOSTICS CORP.
K043305 11/30/2004 ONLINE DAT PHENCYCLIDINE PLUS ROCHE DIAGNOSTICS CORP.
K013278 10/01/2001 TINA-QUANT APOLIPOPROTEIN A-1 VER.2 ROCHE DIAGNOSTICS CORP.
K010237 01/25/2001 ELECSYS HCG+B CALCHECK ROCHE DIAGNOSTICS CORP.
K012359 07/25/2001 TINA-QUANT COMPLEMENT C4 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K012361 07/25/2001 TINA-QUANT COMPLEMENT C3C TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K013249 09/28/2001 TINA-QUANT APOLIPOPROTEIN VER.2 ROCHE DIAGNOSTICS CORP.
K092649 08/28/2009 ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 ROCHE DIAGNOSTICS CORP.
K092888 09/21/2009 ELECSYS TOXO IGG CALCHECK 5 ROCHE DIAGNOSTICS CORP.
K072920 10/15/2007 HANDHELD BASE UNIT ROCHE DIAGNOSTICS CORP.
K000096 01/13/2000 ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 ROCHE DIAGNOSTICS CORP.
K040174 01/26/2004 BILIRUBIN ASSAY ON THE OMNI S ANALYZER ROCHE DIAGNOSTICS CORP.
K990377 02/08/1999 ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV ROCHE DIAGNOSTICS CORP.
K990399 02/09/1999 ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 ROCHE DIAGNOSTICS CORP.
K020831 03/14/2002 PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 ROCHE DIAGNOSTICS CORP.
K030845 03/17/2003 COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING ROCHE DIAGNOSTICS CORP.
K021190 04/15/2002 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 ROCHE DIAGNOSTICS CORP.
K001356 04/28/2000 ONTRAK TESTCUP PRO-5, MODEL 1986678 ROCHE DIAGNOSTICS CORP.
K001421 05/05/2000 ONTRAK TESTCUP 501, MODEL 3016633 ROCHE DIAGNOSTICS CORP.
K001417 05/05/2000 ONTRAK TESTCUP 502, MODEL 3016641 ROCHE DIAGNOSTICS CORP.
K012396 07/27/2001 ONTRAK TESTCARD 9 ROCHE DIAGNOSTICS CORP.
K032311 07/28/2003 ROCHE DIAGNOSTICS OMNI S ANALYZER ROCHE DIAGNOSTICS CORP.
K032437 08/07/2003 CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS ROCHE DIAGNOSTICS CORP.
K092940 09/24/2009 COAGUCHEK XS PLUS PST SYSTEM ROCHE DIAGNOSTICS CORP.
K033491 11/04/2003 ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS ROCHE DIAGNOSTICS CORP.
K033548 11/12/2003 ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER ROCHE DIAGNOSTICS CORP.
K994020 11/26/1999 ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 ROCHE DIAGNOSTICS CORP.
K994017 11/26/1999 ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 ROCHE DIAGNOSTICS CORP.
K994030 11/26/1999 ONTRAK TESTCUP 5, CAT. 07 6481 7 ROCHE DIAGNOSTICS CORP.
K994164 12/09/1999 ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 ROCHE DIAGNOSTICS CORP.
K994165 12/09/1999 ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 ROCHE DIAGNOSTICS CORP.
K003865 12/13/2000 COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP.
K994349 12/23/1999 COAGUCHEK S SYSTEM, MODEL 2138280 ROCHE DIAGNOSTICS CORP.
K011145 03/26/2001 MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 ROCHE DIAGNOSTICS CORP.
K013373 10/11/2001 OMNI C ANALYZER ROCHE DIAGNOSTICS CORP.
K990337 02/03/1999 ONTRAK TESTCUP-5 M2K ROCHE DIAGNOSTICS CORP.
K990409 02/09/1999 ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) ROCHE DIAGNOSTICS CORP.
K990418 02/10/1999 ONTRAK TESTCUP-ER M2K ROCHE DIAGNOSTICS CORP.
K130138 01/18/2013 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM ROCHE DIAGNOSTICS CORP.
K080607 03/04/2008 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 ROCHE DIAGNOSTICS CORP.
K082340 08/15/2008 ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS ROCHE DIAGNOSTICS CORP.
K083444 11/21/2008 C-REACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP.
K070391 02/09/2007 ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K070709 03/14/2007 ROCHE ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K001846 06/19/2000 ELECSYS INSULIN CALCHECK ROCHE DIAGNOSTICS CORP.
K000042 01/06/2000 ELECSYS B-CROSSLAPS CALCHECK ROCHE DIAGNOSTICS CORP.
K003158 10/10/2000 ROCHE DIAGNOSTICS CK-MB ROCHE DIAGNOSTICS CORP.
K000155 01/19/2000 ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K080147 01/22/2008 ELECSYS PROBNP II CALCHECK ROCHE DIAGNOSTICS CORP.
K050231 01/26/2005 ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET ROCHE DIAGNOSTICS CORP.
K050387 02/15/2005 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR ROCHE DIAGNOSTICS CORP.
K000534 02/17/2000 COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II ROCHE DIAGNOSTICS CORP.
K000576 02/22/2000 ELECSYS CORTISOL CALCHECK ROCHE DIAGNOSTICS CORP.
K000568 02/22/2000 HDL CHOLESTEROL PLUS ROCHE DIAGNOSTICS CORP.
K010588 02/27/2001 ELECSYSCA 15-3 II ASSAY ROCHE DIAGNOSTICS CORP.
K060754 03/21/2006 ELECSYS TSH CALSET W/MODELS 04738551 ROCHE DIAGNOSTICS CORP.
K001015 03/29/2000 ELECSYS THYROGLOBULIN CALCHECK ROCHE DIAGNOSTICS CORP.
K001014 03/29/2000 ELECSYS ANTI-TPO CALCHECK ROCHE DIAGNOSTICS CORP.
K011143 04/13/2001 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K011226 04/20/2001 CALIBRATOR FOR AUTOMATED SYSTEMS ROCHE DIAGNOSTICS CORP.
K051297 05/18/2005 ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK ROCHE DIAGNOSTICS CORP.
K051292 05/18/2005 ELECSYS RBC FOLATE HEMOLYZED REAGENT ROCHE DIAGNOSTICS CORP.
K031650 05/28/2003 FERRITIN GENERATION 2 ROCHE DIAGNOSTICS CORP.
K001906 06/22/2000 ELECSYS INSULIN CALSET ROCHE DIAGNOSTICS CORP.
K051890 07/12/2005 ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ROCHE DIAGNOSTICS CORP.
K012397 07/27/2001 URISYS 2400 URINE TEST STRIP ROCHE DIAGNOSTICS CORP.
K002353 08/02/2000 ELECSYS CA 15-3 CALCHECK ROCHE DIAGNOSTICS CORP.
K002609 08/22/2000 TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K032646 08/27/2003 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K002706 08/30/2000 ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI ROCHE DIAGNOSTICS CORP.
K002760 09/05/2000 ELECSYS DHEA-S CALSET ROCHE DIAGNOSTICS CORP.
K013207 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP.
K013206 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP.
K003064 10/02/2000 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 ROCHE DIAGNOSTICS CORP.
K003120 10/05/2000 MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C ROCHE DIAGNOSTICS CORP.
K003174 10/10/2000 ELECSYS DHEA-S ROCHE DIAGNOSTICS CORP.
K003178 10/11/2000 ELECSYS HCG AND BETA TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K003400 11/01/2000 CRP HS TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K003411 11/02/2000 ELECSYS TESTOSTERONE CALSET II ROCHE DIAGNOSTICS CORP.
K003409 11/02/2000 ELECSYS FSH CALSET II ROCHE DIAGNOSTICS CORP.
K043095 11/09/2004 ROCHE DIAGNOSTICS ELECSYS AFP CALSET II ROCHE DIAGNOSTICS CORP.
K043175 11/16/2004 ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE ROCHE DIAGNOSTICS CORP.
K043318 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K043320 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP.
K003772 12/06/2000 ELECSYS DHEA-S CALCHECK ROCHE DIAGNOSTICS CORP.
K003941 12/21/2000 ELECSYS HCG STAT CLASET II ROCHE DIAGNOSTICS CORP.
K003969 12/22/2000 ELECSYS CA 125 II CALSET ROCHE DIAGNOSTICS CORP.
K003967 12/22/2000 CA 125 II CALCHECK ROCHE DIAGNOSTICS CORP.
K042490 09/14/2004 ELECSYS FOLATE II CALSET II ROCHE DIAGNOSTICS CORP.
K101365 05/17/2010 ELECSYS CA 19-9 CALCHECK 5 ROCHE DIAGNOSTICS CORP.
K093700 12/01/2009 ELECSYS HCG STAT CALCHECK 5 ROCHE DIAGNOSTICS CORP.
K030213 01/21/2003 ONLINE DAT II CANNABINOIDS II ROCHE DIAGNOSTICS CORP.
K021505 05/09/2002 ONLINE DAT II METHADONE II ROCHE DIAGNOSTICS CORP.
K021512 05/09/2002 COBAS INTEGRA ONLINE DAT II METHADONE II ROCHE DIAGNOSTICS CORP.
K031775 06/10/2003 PRECISET DAT PLUS I CALIBRATORS ROCHE DIAGNOSTICS CORP.
K031856 06/16/2003 PRECISET TDM I AND PRECISET TDM II CALIBRATORS ROCHE DIAGNOSTICS CORP.
K031902 06/20/2003 ONLINE TDM CARBAMAZEPINE ROCHE DIAGNOSTICS CORP.
K032279 07/24/2003 ONLINE TDM AMIKA ROCHE DIAGNOSTICS CORP.
K033165 09/30/2003 PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS ROCHE DIAGNOSTICS CORP.
K023281 10/01/2002 ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP.
K023296 10/02/2002 COBAS INTEGRA ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP.
K033246 10/07/2003 PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS ROCHE DIAGNOSTICS CORP.
K033306 10/14/2003 PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS ROCHE DIAGNOSTICS CORP.
K013482 10/19/2001 ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP.
K053165 11/14/2005 ISE INDIRECT NA, K, CL FOR GEN.2 ROCHE DIAGNOSTICS CORP.
K043211 11/19/2004 ONLINE DAT BARBITURATES PLUS ROCHE DIAGNOSTICS CORP.
K043303 11/30/2004 ONLINE DAT PROPOXYPHENE PLUS ROCHE DIAGNOSTICS CORP.
K043327 12/02/2004 ONLINE DAT BENZODIAZEPINES PLUS ROCHE DIAGNOSTICS CORP.
K080811 03/24/2008 TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET ROCHE DIAGNOSTICS CORP.
K072638 09/18/2007 ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 ROCHE DIAGNOSTICS CORP.
K062972 09/29/2006 PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS ROCHE DIAGNOSTICS CORP.
K073277 11/21/2007 ROCHE-CREACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP.
K991598 05/10/1999 COBAS INTEGRA ACETAMINOPHEN ROCHE DIAGNOSTICS CORP.
K991597 05/10/1999 COBAS INTEGRA AMIKACIN MAB ROCHE DIAGNOSTICS CORP.
K992890 08/27/1999 ROCHE COBAS INTEGRA OPIATES 300/2000 ROCHE DIAGNOSTICS CORP.
K991443 04/26/1999 ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) ROCHE DIAGNOSTICS CORP.
K991440 04/26/1999 ROCHE COBAS INTEGRA SERUM BARBITURATES ROCHE DIAGNOSTICS CORP.
K011684 05/30/2001 INFLUENZA A/B RAPID TEST, CAT NO 2158 663 ROCHE DIAGNOSTICS CORP.
K992492 07/26/1999 PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM ROCHE DIAGNOSTICS CORP.
K992851 08/24/1999 ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM ROCHE DIAGNOSTICS CORP.
K993048 09/10/1999 ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST ROCHE DIAGNOSTICS CORP.
K004010 12/26/2000 ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS ROCHE DIAGNOSTICS CORP.
K083764 12/18/2008 AMPHETAMINES II ROCHE DIAGNOSTICS CORP.
K093664 11/27/2009 AMPHETAMINES II ASSAY ROCHE DIAGNOSTICS CORP.
K000365 02/04/2000 ACCU-CHEK ADVANTAGE METER ROCHE DIAGNOSTICS CORP.
K000364 02/04/2000 ACCU-CHEK COMPLETE METER ROCHE DIAGNOSTICS CORP.
K010362 02/06/2001 ACCU-CHEK COMFORT CURVE TEST STRIP ROCHE DIAGNOSTICS CORP.
K030428 02/10/2003 ROCHE ONLINE TDM PHENYTOIN ROCHE DIAGNOSTICS CORP.
K020704 03/04/2002 ROCHE ONLINE GENTAMICIN ROCHE DIAGNOSTICS CORP.
K020740 03/06/2002 ROCHE ONLINE THEOPHYLLINE ROCHE DIAGNOSTICS CORP.
K021448 05/06/2002 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K021827 06/04/2002 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K011738 06/05/2001 ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP.
K001907 06/22/2000 CAMIT DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP.
K032049 07/02/2003 ROCHE ONLINE TDM VALPROIC ACID ROCHE DIAGNOSTICS CORP.
K012210 07/16/2001 MODIFICATION TO ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP.
K012324 07/23/2001 ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K032332 07/29/2003 ROCHE ONLINE TDM QUINIDINE ROCHE DIAGNOSTICS CORP.
K032334 07/29/2003 ROCHE ONLINE TDM LIDOCAINE ROCHE DIAGNOSTICS CORP.
K993829 11/12/1999 ACCU-CHEK SIMPLICITY SYSTEM ROCHE DIAGNOSTICS CORP.
K013757 11/13/2001 ROCHE ACETAMINOPHEN ROCHE DIAGNOSTICS CORP.
K003846 12/12/2000 ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP.
K992900 08/30/1999 PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA ROCHE DIAGNOSTICS CORP.
K990460 02/12/1999 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) ROCHE DIAGNOSTICS CORP.
K990594 02/24/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTICS CORP.
K990595 02/24/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B ROCHE DIAGNOSTICS CORP.
K990992 03/24/1999 INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC ROCHE DIAGNOSTICS CORP.
K001468 05/10/2000 ELECSYS CA 15-3 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K002148 07/17/2000 ELECSYS HCG TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K992680 08/10/1999 ELECSYS PARATHYROID HORMONE TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K992981 09/03/1999 ELECSYS ESTRADIOL CALSET II ROCHE DIAGNOSTICS CORP.
K993360 10/06/1999 PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA ROCHE DIAGNOSTICS CORP.
K003261 10/18/2000 CREATININE PLUS ROCHE DIAGNOSTICS CORP.
K993642 10/28/1999 ELECSYS PARATHYROID HORMONE CALCHECK ROCHE DIAGNOSTICS CORP.
K993706 11/02/1999 ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K000270 01/28/2000 ELECSYS CORTISOL TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K060585 03/07/2006 ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH ROCHE DIAGNOSTICS CORP.
K053426 12/08/2005 ROCHE ELECSYS ANTI-TG ROCHE DIAGNOSTICS CORP.
K060755 03/21/2006 ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK ROCHE DIAGNOSTICS CORP.
K022516 07/30/2002 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K033612 11/17/2003 FACTOR II (PROTHROMBIN) G20210A KIT ROCHE DIAGNOSTICS CORP.
K033734 11/28/2003 LIGHTCYCLER INSTRUMENT VERSION 1.2 ROCHE DIAGNOSTICS CORP.
DEN030005 12/08/2003 FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP.
K101075 04/19/2010 ELECSYS INSULIN CALCHECK 5 ROCHE DIAGNOSTICS CORP.
K091601 06/03/2009 ELECYS ANTI-CCP CALCHECK ROCHE DIAGNOSTICS CORP.
K092848 09/16/2009 ELECSYS TROPONIN T CALCHECK 5 ROCHE DIAGNOSTICS CORP.
K093421 11/03/2009 ELECSYS TESTOSTERONE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K080227 01/30/2008 ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM ROCHE DIAGNOSTICS CORP.
K070585 03/01/2007 ACCU-CHEK PERFORMA SYSTEM ROCHE DIAGNOSTICS CORP.
K060620 03/08/2006 ACCU-CHEK AVIVA TEST STRIPS ROCHE DIAGNOSTICS CORP.
K050760 03/24/2005 ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP.
K040796 03/29/2004 ACCU-CHEK GO SYSTEM ROCHE DIAGNOSTICS CORP.
K050872 04/06/2005 ACCU-CHEK INTEGRA SYSTEM ROCHE DIAGNOSTICS CORP.
K101196 04/29/2010 ACCU-CHEK ULTRFLEX INFUSION SET ROCHE DIAGNOSTICS CORP.
K021513 05/09/2002 ACCU-CHEK ADVANTAGE MODULE ROCHE DIAGNOSTICS CORP.
K031755 06/06/2003 ACCU-CHEK COMPACT TEST STRIP ROCHE DIAGNOSTICS CORP.
K022171 07/03/2002 ACCU-CHEK COMPACT SYSTEM ROCHE DIAGNOSTICS CORP.
K062395 08/16/2006 ACCU-CHEK SMART PIX ROCHE DIAGNOSTICS CORP.
K032552 08/19/2003 ACCU-CHEK ADVANTAGE SYSTEM ROCHE DIAGNOSTICS CORP.
K043474 12/16/2004 ACCU-CHEK AVIVA SYSTEM ROCHE DIAGNOSTICS CORP.
K014139 12/17/2001 DIABETES ASSISTANT SOFTWARE ROCHE DIAGNOSTICS CORP.
K043529 12/21/2004 ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE ROCHE DIAGNOSTICS CORP.
K020369 02/04/2002 ELECSYS ANTI-TG CALCHECK ROCHE DIAGNOSTICS CORP.
K040264 02/04/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF ROCHE DIAGNOSTICS CORP.
K040280 02/06/2004 PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS ROCHE DIAGNOSTICS CORP.
K040431 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 ROCHE DIAGNOSTICS CORP.
K040434 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 ROCHE DIAGNOSTICS CORP.
K040435 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 ROCHE DIAGNOSTICS CORP.
K020672 03/01/2002 ELECSYS ANTI-TG TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K030740 03/10/2003 MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K020883 03/18/2002 ELECSYS PROBNP CALCHECK ROCHE DIAGNOSTICS CORP.
K021218 04/17/2002 ELECSYS CORTISOL TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K031756 06/06/2003 ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY ROCHE DIAGNOSTICS CORP.
K031824 06/13/2003 COBAS INTEGRA CHOLESTEROL GEN. 2 ROCHE DIAGNOSTICS CORP.
K031880 06/18/2003 AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL ROCHE DIAGNOSTICS CORP.
K031879 06/18/2003 COBAS INTEGRA CARBON DIOXIDE ASSAY ROCHE DIAGNOSTICS CORP.
K032089 07/07/2003 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC ROCHE DIAGNOSTICS CORP.
K012286 07/20/2001 MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K012287 07/20/2001 MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K012371 07/26/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP.
K012399 07/27/2001 MODIFICATION TO ELECSYS FSH II CALSET ROCHE DIAGNOSTICS CORP.
K012393 07/27/2001 TINA-QUANT TRANSFERRIN VER.2 ROCHE DIAGNOSTICS CORP.
K032336 07/29/2003 TINA-QUANT CRP (LATEX) ROCHE DIAGNOSTICS CORP.
K032377 08/01/2003 ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID ROCHE DIAGNOSTICS CORP.
K022654 08/09/2002 MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB ROCHE DIAGNOSTICS CORP.
K032535 08/18/2003 MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K033009 09/26/2003 ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 ROCHE DIAGNOSTICS CORP.
K033185 10/01/2003 COBAS INTEGRA ALP IFCC GEN.2 ROCHE DIAGNOSTICS CORP.
K033501 11/05/2003 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) ROCHE DIAGNOSTICS CORP.
K033610 11/17/2003 HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP.
K024098 12/12/2002 COBAS INTEGRA CREATININE PLUS VER.2 ASSAY ROCHE DIAGNOSTICS CORP.
K080092 01/14/2008 ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB ROCHE DIAGNOSTICS CORP.
K000784 03/10/2000 THE CARDIAC READER SYSTEM ROCHE DIAGNOSTICS CORP.
K061683 06/15/2006 TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062203 08/01/2006 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K062239 08/02/2006 GLUCOSE HK NEW FORMULATION TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K063684 12/12/2006 COBAS LITHIUM ROCHE DIAGNOSTICS CORP.
K063823 12/26/2006 COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP.
K062925 09/28/2006 COAGUCHEK XS SYSTEM ROCHE DIAGNOSTICS CORP.
K031698 06/02/2003 ELECYS SHBG CALCHECK ROCHE DIAGNOSTICS CORP.
K072617 09/17/2007 ELECSYS RUBELLA IGG IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K072714 09/25/2007 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K073501 12/13/2007 ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG ROCHE DIAGNOSTICS CORP.
K050113 01/18/2005 TINA-QUANT IGG GEN.2 ROCHE DIAGNOSTICS CORP.
K040157 01/23/2004 ELECSYS C-PEPTIDE CALCHECK ROCHE DIAGNOSTICS CORP.
K040245 02/03/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) ROCHE DIAGNOSTICS CORP.
K040733 03/22/2004 ELECSYS TROPONIN T STAT TEST ROCHE DIAGNOSTICS CORP.
K061093 04/19/2006 CHOLINESTERASE GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K031299 04/24/2003 ELECSYS LH CALSET II ROCHE DIAGNOSTICS CORP.
K041227 05/10/2004 MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA ROCHE DIAGNOSTICS CORP.
K051382 05/27/2005 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K031717 06/03/2003 ELECSYS SHBG IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K031990 06/27/2003 ELECSYS PRECICONTROL TROPONIN T ROCHE DIAGNOSTICS CORP.
K041812 07/06/2004 MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) ROCHE DIAGNOSTICS CORP.
K042389 09/02/2004 MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA ROCHE DIAGNOSTICS CORP.
K052464 09/08/2005 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST ROCHE DIAGNOSTICS CORP.
K042485 09/13/2004 TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) ROCHE DIAGNOSTICS CORP.
K053287 11/25/2005 COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE DIAGNOSTICS CORP.
K053289 11/25/2005 COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE DIAGNOSTICS CORP.
K033873 12/15/2003 ELECSYS C-PEPTIDE CALSET ROCHE DIAGNOSTICS CORP.
K033937 12/19/2003 ELECSYS PRECICONTROL MULTIANALYTE ROCHE DIAGNOSTICS CORP.
K053603 12/23/2005 C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS ROCHE DIAGNOSTICS CORP.


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