Hoffmann-La Roche, Inc.
FDA 510(k) medical device clearances.
Top product codes for Hoffmann-La Roche, Inc.
Recent clearances by Hoffmann-La Roche, Inc.
- K850727 — BHCG-ROCHE EIA
- K831694 — RENAK
- K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
- K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
- K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE
- K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
- K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
- K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
- K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
- K823572 — COBAS STANDARDS FOR CREATININE
- K823573 — COBAS REAGENT FOR CREATININE
- K823574 — COBAS REAGENT FOR ALBUMIN
- K823575 — COBAS STANDARDS FOR ALBUMIN
- K823576 — COBAS STANDARD FOR TOTAL PROTEIN
- K823577 — COBAS REAGENT FOR CALCIUM
- K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
- K823579 — COBAS REAGENT FOR TOTAL PROTEIN
- K823580 — COBAS REAGENT FOR INORGANIC PHOSPHORUS
- K822219 — HUMAN PLASMA CONTROL FOR CEA-ROCHE
- K823212 — ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
- K820942 — ROCHE(R) B-HCG RIA URINE STANDARD
- K820613 — ROCHE B-HCG RIA
- K820614 — ROCHE B-HCG STANDARDS
- K820391 — ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI
- K812986 — AGGLUTEX AMPHETAMINE TEST KIT
- K812985 — AGGLUTEX MORPHINE TEST KIT
- K812988 — AGGLUTEX BARBITURATES TEST KIT
- K812987 — AGGLUTEX METHAQUALONE TEST KIT
- K812730 — SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
- K812729 — SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
- K812731 — SEPTI-CHECK BLOOD CULTURE SLIDE
- K812732 — SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
- K811116 — HCG RADIOIMMUNOASSAY
- K810905 — ISOMUNE-CK
- K801244 — ROCHE HCG STANDARDS
- K792658 — COBAS-BLO REAGENTS (LACTATE DEHYDRO
- K792671 — COBAS-BIO CENTRIFUGAL ANALYZER
- K792657 — SENSI-SLIDE
- K791373 — ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
- K791206 — HCG RIA PREGNANCY TEST
- K790655 — ABUSCREEN RIA FOR PHENCYCLIDINE
- K790485 — AMYLOCHROME STAT SEPARATOR, TEST
- K790357 — CPK-CS
- K790267 — SENSI-TEX
- K781236 — ENTEROTUBE II
- K780428 — ROCHE TSH RIA
- K771623 — T3 RIA
- K770467 — IN VITRO DIAGNOSTIC TEST
- K760089 — TEST, IN-VITRO DIAGNOSTIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.