Roche Diagnostics Corp.
Roche Diagnostics Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2013.
Clearances by Roche Diagnostics Corp. — page 3
201–264 of 264- K010237 — ELECSYS HCG+B CALCHECK
- K003409 — ELECSYS FSH CALSET II
- K003941 — ELECSYS HCG STAT CLASET II
- K003174 — ELECSYS DHEA-S
- K003967 — CA 125 II CALCHECK
- K003969 — ELECSYS CA 125 II CALSET
- K003772 — ELECSYS DHEA-S CALCHECK
- K003120 — MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
- K003158 — ROCHE DIAGNOSTICS CK-MB
- K003178 — ELECSYS HCG AND BETA TEST SYSTEM
- K003261 — CREATININE PLUS
- K001468 — ELECSYS CA 15-3 TEST SYSTEM
- K002760 — ELECSYS DHEA-S CALSET
- K994349 — COAGUCHEK S SYSTEM, MODEL 2138280
- K001907 — CAMIT DIABETES MANAGEMENT SOFTWARE
- K002609 — TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K002148 — ELECSYS HCG TEST SYSTEM
- K002353 — ELECSYS CA 15-3 CALCHECK
- K000568 — HDL CHOLESTEROL PLUS
- K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
- K001906 — ELECSYS INSULIN CALSET
- K001421 — ONTRAK TESTCUP 501, MODEL 3016633
- K001356 — ONTRAK TESTCUP PRO-5, MODEL 1986678
- K001417 — ONTRAK TESTCUP 502, MODEL 3016641
- K001846 — ELECSYS INSULIN CALCHECK
- K001014 — ELECSYS ANTI-TPO CALCHECK
- K000784 — THE CARDIAC READER SYSTEM
- K000155 — ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
- K001015 — ELECSYS THYROGLOBULIN CALCHECK
- K000096 — ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
- K994164 — ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
- K994165 — ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
- K000534 — COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
- K000576 — ELECSYS CORTISOL CALCHECK
- K000042 — ELECSYS B-CROSSLAPS CALCHECK
- K000270 — ELECSYS CORTISOL TEST SYSTEM
- K000364 — ACCU-CHEK COMPLETE METER
- K000365 — ACCU-CHEK ADVANTAGE METER
- K994017 — ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
- K994020 — ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
- K994030 — ONTRAK TESTCUP 5, CAT. 07 6481 7
- K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- K993048 — ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
- K993829 — ACCU-CHEK SIMPLICITY SYSTEM
- K993642 — ELECSYS PARATHYROID HORMONE CALCHECK
- K992900 — PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K993360 — PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
- K992890 — ROCHE COBAS INTEGRA OPIATES 300/2000
- K992492 — PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
- K990992 — INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
- K992680 — ELECSYS PARATHYROID HORMONE TEST SYSTEM
- K992981 — ELECSYS ESTRADIOL CALSET II
- K991597 — COBAS INTEGRA AMIKACIN MAB
- K991598 — COBAS INTEGRA ACETAMINOPHEN
- K991440 — ROCHE COBAS INTEGRA SERUM BARBITURATES
- K991443 — ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
- K990399 — ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
- K990409 — ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
- K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
- K990595 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
- K990418 — ONTRAK TESTCUP-ER M2K
- K990460 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
- K990377 — ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
- K990337 — ONTRAK TESTCUP-5 M2K
Data sourced from openFDA. This site is unofficial and independent of the FDA.