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Hoffmann-La Roche, Inc.

49 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
BHCG-ROCHE EIA (K850727)Hoffmann-La Roche, Inc.1985-06-25
RENAK (K831694)Hoffmann-La Roche, Inc.1983-07-19
ABUSCREEN RADIOUMMUNOASSAY--URINE (K830462)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (K830480)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (K830460)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (K830481)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (K830482)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (K830479)Hoffmann-La Roche, Inc.1983-03-10
COBAS REAGENT FOR CREATININE (K823573)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR INORGANIC PHOSPHORUS (K823580)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR ALBUMIN (K823574)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARDS FOR ALBUMIN (K823575)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARD FOR TOTAL PROTEIN (K823576)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARDS FOR CREATININE (K823572)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR TOTAL PROTEIN (K823579)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR CALCIUM (K823577)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (K823578)Hoffmann-La Roche, Inc.1983-01-07
HUMAN PLASMA CONTROL FOR CEA-ROCHE (K822219)Hoffmann-La Roche, Inc.1982-12-28
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE (K823212)Hoffmann-La Roche, Inc.1982-11-29
ROCHE(R) B-HCG RIA URINE STANDARD (K820942)Hoffmann-La Roche, Inc.1982-05-03
ROCHE B-HCG STANDARDS (K820614)Hoffmann-La Roche, Inc.1982-04-01
ROCHE B-HCG RIA (K820613)Hoffmann-La Roche, Inc.1982-04-01
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI (K820391)Hoffmann-La Roche, Inc.1982-03-08
AGGLUTEX AMPHETAMINE TEST KIT (K812986)Hoffmann-La Roche, Inc.1982-01-22
AGGLUTEX BARBITURATES TEST KIT (K812988)Hoffmann-La Roche, Inc.1981-12-31
AGGLUTEX MORPHINE TEST KIT (K812985)Hoffmann-La Roche, Inc.1981-12-31
AGGLUTEX METHAQUALONE TEST KIT (K812987)Hoffmann-La Roche, Inc.1981-12-22
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE (K812730)Hoffmann-La Roche, Inc.1981-10-23
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE (K812732)Hoffmann-La Roche, Inc.1981-10-19
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE (K812729)Hoffmann-La Roche, Inc.1981-10-19
SEPTI-CHECK BLOOD CULTURE SLIDE (K812731)Hoffmann-La Roche, Inc.1981-10-19
HCG RADIOIMMUNOASSAY (K811116)Hoffmann-La Roche, Inc.1981-05-13
ISOMUNE-CK (K810905)Hoffmann-La Roche, Inc.1981-04-14
ROCHE HCG STANDARDS (K801244)Hoffmann-La Roche, Inc.1980-06-20
COBAS-BLO REAGENTS (LACTATE DEHYDRO (K792658)Hoffmann-La Roche, Inc.1980-01-17
COBAS-BIO CENTRIFUGAL ANALYZER (K792671)Hoffmann-La Roche, Inc.1980-01-17
SENSI-SLIDE (K792657)Hoffmann-La Roche, Inc.1980-01-16
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS (K791373)Hoffmann-La Roche, Inc.1979-10-26
HCG RIA PREGNANCY TEST (K791206)Hoffmann-La Roche, Inc.1979-07-30
ABUSCREEN RIA FOR PHENCYCLIDINE (K790655)Hoffmann-La Roche, Inc.1979-06-15
AMYLOCHROME STAT SEPARATOR, TEST (K790485)Hoffmann-La Roche, Inc.1979-05-03
CPK-CS (K790357)Hoffmann-La Roche, Inc.1979-04-04
SENSI-TEX (K790267)Hoffmann-La Roche, Inc.1979-03-21
ENTEROTUBE II (K781236)Hoffmann-La Roche, Inc.1978-08-31
ROCHE TSH RIA (K780428)Hoffmann-La Roche, Inc.1978-03-30
T3 RIA (K771623)Hoffmann-La Roche, Inc.1977-09-20
IN VITRO DIAGNOSTIC TEST (K770467)Hoffmann-La Roche, Inc.1977-04-27
TEST, IN-VITRO DIAGNOSTIC (K760089)Hoffmann-La Roche, Inc.1976-07-20

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