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. |