Medical Device Manufacturer · US , Mchenry , IL

Hoffmann-La Roche, Inc. - FDA 510(k) Cleared Devices

49 submissions · 49 cleared · Since 1976
49
Total
49
Cleared
0
Denied
49 devices
26-49 of 49
Cleared Dec 31, 1981
AGGLUTEX MORPHINE TEST KIT
K812985 · DDF
Toxicology · 66d
Cleared Dec 31, 1981
AGGLUTEX BARBITURATES TEST KIT
K812988 · DKN
Toxicology · 66d
Cleared Dec 22, 1981
AGGLUTEX METHAQUALONE TEST KIT
K812987 · KXS
Toxicology · 57d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · JSG
Microbiology · 25d
Cleared Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · JSG
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · JSI
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · JSG
Microbiology · 21d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116 · JHI
Chemistry · 19d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905 · JHW
Chemistry · 11d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Chemistry · 24d
Cleared Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · CFJ
Chemistry · 22d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · JJG
Chemistry · 21d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Chemistry · 21d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · CFE
Chemistry · 94d
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206 · JHI
Chemistry · 31d
Cleared Jun 15, 1979
ABUSCREEN RIA FOR PHENCYCLIDINE
K790655 · LCL
Toxicology · 71d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · JKA
Chemistry · 52d
Cleared Apr 04, 1979
CPK-CS
K790357 · JHT
Chemistry · 40d
Cleared Mar 21, 1979
SENSI-TEX
K790267 · JHJ
Chemistry · 43d
Cleared Aug 31, 1978
ENTEROTUBE II
K781236 · JSS
Microbiology · 42d
Cleared Mar 30, 1978
ROCHE TSH RIA
K780428 · JLW
Chemistry · 13d
Cleared Sep 20, 1977
T3 RIA
K771623 · CDP
Toxicology · 26d
Cleared Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
K770467
Immunology · 48d
Cleared Jul 20, 1976
TEST, IN-VITRO DIAGNOSTIC
K760089
Immunology · 29d
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