Roche Diagnostics Corp.
Roche Diagnostics Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2013.
Top product codes for Roche Diagnostics Corp.
Recent clearances by Roche Diagnostics Corp.
1–100 of 264- K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
- K101365 — ELECSYS CA 19-9 CALCHECK 5
- K100853 — COBAS 8000 MODULAR SERIES ANALYZER
- K101196 — ACCU-CHEK ULTRFLEX INFUSION SET
- K093664 — AMPHETAMINES II ASSAY
- K101075 — ELECSYS INSULIN CALCHECK 5
- K093421 — ELECSYS TESTOSTERONE II IMMUNOASSAY
- K092848 — ELECSYS TROPONIN T CALCHECK 5
- K092940 — COAGUCHEK XS PLUS PST SYSTEM
- K093700 — ELECSYS HCG STAT CALCHECK 5
- K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
- K083764 — AMPHETAMINES II
- K092888 — ELECSYS TOXO IGG CALCHECK 5
- K091601 — ELECYS ANTI-CCP CALCHECK
- K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
- K083444 — C-REACTIVE PROTEIN (LATEX)
- K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY
- K080092 — ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
- K080811 — TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
- K073501 — ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
- K080227 — ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
- K080607 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
- K072714 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
- K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
- K063684 — COBAS LITHIUM
- K073277 — ROCHE-CREACTIVE PROTEIN (LATEX)
- K080147 — ELECSYS PROBNP II CALCHECK
- K072920 — HANDHELD BASE UNIT
- K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
- K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
- K070709 — ROCHE ELECSYS PTH TEST SYSTEM
- K070585 — ACCU-CHEK PERFORMA SYSTEM
- K062395 — ACCU-CHEK SMART PIX
- K070391 — ELECSYS PTH TEST SYSTEM
- K070200 — TDM CONTROL SET, MODEL CAT# 04521536
- K062203 — TINA-QUANT D-DIMER TEST SYSTEM
- K062114 — CERULOPLASMIN, MODEL 2055953
- K062379 — COBAS INTEGRA CERULOPLASMIN
- K062925 — COAGUCHEK XS SYSTEM
- K063823 — COAGUCHEK XS PT CONTROLS
- K063543 — COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
- K062972 — PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
- K062319 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
- K062239 — GLUCOSE HK NEW FORMULATION TEST SYSTEM
- K060773 — ONLINE TDM PROCAINAMIDE
- K060738 — TDM N-ACETYLPROCAINAMIDE
- K060620 — ACCU-CHEK AVIVA TEST STRIPS
- K053287 — COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K053289 — COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K060690 — ONLINE VALPROIC ACID
- K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
- K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM
- K060853 — ONLINE TDM TOBRAMYCIN
- K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K061048 — COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
- K060586 — ENZYME IMMUNOASSAY, VANCOMYCIN
- K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
- K060754 — ELECSYS TSH CALSET W/MODELS 04738551
- K060755 — ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
- K060429 — TDM CONTROL SET
- K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
- K053603 — C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
- K053426 — ROCHE ELECSYS ANTI-TG
- K053165 — ISE INDIRECT NA, K, CL FOR GEN.2
- K051382 — ELECSYS PROBNP IMMUNOASSAY
- K051543 — ELECSYS PRECICONTROL BONE
- K052464 — TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
- K050760 — ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
- K051297 — ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
- K051592 — MODIFICATION TO ACCU-CHEK GO SYSTEM
- K052002 — IRON STANDARD
- K051890 — ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
- K051687 — ELECSYS PRECICONTROL UNIVERSAL
- K050231 — ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
- K051185 — ELECSYS CA 19-9 CALCHECK
- K051517 — ELECSYS PRECICONTROL ANEMIA
- K051292 — ELECSYS RBC FOLATE HEMOLYZED REAGENT
- K050872 — ACCU-CHEK INTEGRA SYSTEM
- K043474 — ACCU-CHEK AVIVA SYSTEM
- K050387 — ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
- K043529 — ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
- K043303 — ONLINE DAT PROPOXYPHENE PLUS
- K050113 — TINA-QUANT IGG GEN.2
- K043327 — ONLINE DAT BENZODIAZEPINES PLUS
- K043305 — ONLINE DAT PHENCYCLIDINE PLUS
- K043211 — ONLINE DAT BARBITURATES PLUS
- K043318 — MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
- K043320 — MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
- K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
- K043095 — ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
- K042485 — TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
- K042490 — ELECSYS FOLATE II CALSET II
- K042389 — MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
- K033491 — ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
- K041812 — MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
- K041227 — MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K040733 — ELECSYS TROPONIN T STAT TEST
- K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- K040796 — ACCU-CHEK GO SYSTEM
- K040264 — CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
Data sourced from openFDA. This site is unofficial and independent of the FDA.