Roche Diagnostics Corp.
FDA 510(k) medical device clearances.
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.