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Roche Diagnostics

183 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 (K112624)Roche Diagnostics2012-09-10
ELECSYS HSV-2 IGG IMMUNOASSAY (K121895)Roche Diagnostics2012-08-24
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625)Roche Diagnostics2012-07-25
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546)Roche Diagnostics2012-07-24
ACCU-CHECK COMBO SYSTEM (K111353)Roche Diagnostics2012-07-17
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188)Roche Diagnostics2012-05-14
ELECSYS LH CALCHECK 5 (K121279)Roche Diagnostics2012-05-10
CALCIUM GEN. 2 (K113521)Roche Diagnostics2012-05-08
GLUCOSE TEST SYSTEM (K113137)Roche Diagnostics2012-01-06
ROCHE ACETAMINOPHEN ASSAY (K110726)Roche Diagnostics2011-12-23
TINA-QUANT HBA1C GEN.2 (K110313)Roche Diagnostics2011-12-23
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM (K101299)Roche Diagnostics2011-09-21
ELECSYS MYOGLOBIN CALCHECK 5 (K112113)Roche Diagnostics2011-09-14
ELECSYS N-MID OSTEOCALCIN CALCHECK 5 (K112104)Roche Diagnostics2011-08-25
ELECSYS T3 CALCHECK 5 (K111552)Roche Diagnostics2011-07-21
ELECSYS PRECICONTROL VARIA 3 (K111506)Roche Diagnostics2011-07-08
ELECSYS SHBG CALCHECK 5 (K111349)Roche Diagnostics2011-06-09
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (K103716)Roche Diagnostics2011-05-12
ELECSYS PROLACTIN II CALCHECK 5 (K110613)Roche Diagnostics2011-05-12
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID (K110446)Roche Diagnostics2011-05-03
ROCHE FLUDI METHAMPHETAMINE (K093884)Roche Diagnostics2011-02-25
ELECSYS ANTI-TPO CALSET (K103171)Roche Diagnostics2011-02-11
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A (K093867)Roche Diagnostics2011-02-11
ROCHE ORAL FLUID COCAINE (K101160)Roche Diagnostics2011-02-11
ORAL FLUID PHENCYCLIDINE (K093989)Roche Diagnostics2011-01-25
ELECYSYS SHBG (K102814)Roche Diagnostics2011-01-20
ELECSYS DHEA-S CALCHECK 5 (K103402)Roche Diagnostics2011-01-07
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 (K103221)Roche Diagnostics2010-12-23
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH (K103099)Roche Diagnostics2010-12-06
ELECSYS PTH CALCHECK 5 (K103162)Roche Diagnostics2010-11-18
ELECSYS CA 125 II CALCHECK 5 (K102086)Roche Diagnostics2010-11-01
ELECSYS IGE CALCHECK 5 (K102269)Roche Diagnostics2010-10-07
ELECSYS CEA CALCHECK 5 (K101856)Roche Diagnostics2010-10-05
TINA-QUANT ALBUMIN GEN 2 (K101203)Roche Diagnostics2010-09-10
ELECSYS FERRITIN CALCHECK 5 (K102267)Roche Diagnostics2010-09-10
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM (K101456)Roche Diagnostics2010-09-08
PRECICONTROL CLINCHEM MULTI 1 AND 2 (K102016)Roche Diagnostics2010-09-01
ELECSYS DIGOXIN CALCHECK 5 (K102044)Roche Diagnostics2010-08-31
ELECSYS PRECICONTROL MULTIMARKER (K102157)Roche Diagnostics2010-08-27
TINA-QUANT FERRITIN GEN. 4 (K100538)Roche Diagnostics2010-06-22
ANTI-HAV IGM (K093955)Roche Diagnostics2010-06-22
ELECSYS FOLATE III CALCHECK 5 (K094031)Roche Diagnostics2010-04-27
ELECSYS C-PEPTIDE CALCHECK 5 (K100810)Roche Diagnostics2010-04-26
ELECSYS TSH CALCHECK 5 (K093836)Roche Diagnostics2010-04-15
COBAS U411 TEST SYSTEM (K093555)Roche Diagnostics2010-04-02
ELECSYS TROPONIN I CALCHECK 5 (K100594)Roche Diagnostics2010-04-01
ELECSYS CK-MB CALCHECK 5 (K093582)Roche Diagnostics2010-03-29
TINA-QUANT CERULOPLASMIN (K091741)Roche Diagnostics2010-03-18
COAGUCHEK XS PRO SYSTEM (K093460)Roche Diagnostics2010-03-18
ELECSYS RUBELLA IGM IMMUNOASSAY (K092322)Roche Diagnostics2010-03-12
ELECSYS PROBNP II CALCHECK 5 (K092169)Roche Diagnostics2009-12-16
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY (K092603)Roche Diagnostics2009-12-04
ELECSYS HCG+B CALCHECK 5 (K092168)Roche Diagnostics2009-11-16
ELECSYS PRECICONTROL THYROAB (K092320)Roche Diagnostics2009-11-03
ELECSYS RUBELLA IGGA CALCHECK 5 (K092585)Roche Diagnostics2009-10-30
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260)Roche Diagnostics2009-10-16
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699)Roche Diagnostics2009-08-19
ELECSYS PRECICONTROL UNIVERSAL (K090541)Roche Diagnostics2009-07-02
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 (K090939)Roche Diagnostics2009-06-18
ELECSYS RUBELLA IGG CALCHECK (K090311)Roche Diagnostics2009-05-05
ELECSYS TOXO IGG CALCHECK (K083655)Roche Diagnostics2009-02-12
COBAS INTEGRA 400/800 BILIRUBIN TOTAL (K081193)Roche Diagnostics2009-01-16
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K082595)Roche Diagnostics2008-10-28
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (K081338)Roche Diagnostics2008-09-11
ELECSYS ANTI-TSHR CALCHECK (K080643)Roche Diagnostics2008-08-22
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K081389)Roche Diagnostics2008-07-15
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET (K072437)Roche Diagnostics2008-02-05
ELECSYS CORTISOL TEST SYSTEM (K070788)Roche Diagnostics2007-10-05
TOTAL PROTEIN URINE/CSF GEN.3 (K071239)Roche Diagnostics2007-09-14
COBAS C 111 ANALYZER (K071211)Roche Diagnostics2007-07-30
COAGUCHEK XS PLUS SYSTEM (K071041)Roche Diagnostics2007-05-11
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520)Roche Diagnostics2007-02-16
ELECSYS IGE II IMMUNOASSAY (K061970)Roche Diagnostics2006-08-31
COAGUCHEK XS SYSTEM (K060978)Roche Diagnostics2006-08-11
COBAS 6000 SERIES SYSTEM (K060373)Roche Diagnostics2006-03-13
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK (K053059)Roche Diagnostics2005-11-28
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET (K052982)Roche Diagnostics2005-10-28
ISE COMPENSATOR (K052193)Roche Diagnostics2005-10-03
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101)Roche Diagnostics2005-08-26
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE (K051376)Roche Diagnostics2005-08-23
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) (K051752)Roche Diagnostics2005-07-11
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) (K050423)Roche Diagnostics2005-04-22
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC (K050026)Roche Diagnostics2005-01-31
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