Hoffmann-La Roche, Inc. - FDA 510(k) Cleared Devices
49
Total
49
Cleared
0
Denied
49 devices
Cleared
Dec 31, 1981
AGGLUTEX MORPHINE TEST KIT
Toxicology
66d
Cleared
Dec 31, 1981
AGGLUTEX BARBITURATES TEST KIT
Toxicology
66d
Cleared
Dec 22, 1981
AGGLUTEX METHAQUALONE TEST KIT
Toxicology
57d
Cleared
Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
Microbiology
25d
Cleared
Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
Microbiology
21d
Cleared
Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
Microbiology
21d
Cleared
Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
Microbiology
21d
Cleared
May 13, 1981
HCG RADIOIMMUNOASSAY
Chemistry
19d
Cleared
Apr 14, 1981
ISOMUNE-CK
Chemistry
11d
Cleared
Jun 20, 1980
ROCHE HCG STANDARDS
Chemistry
24d
Cleared
Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
Chemistry
22d
Cleared
Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
Chemistry
21d
Cleared
Jan 16, 1980
SENSI-SLIDE
Chemistry
21d
Cleared
Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
Chemistry
94d
Cleared
Jul 30, 1979
HCG RIA PREGNANCY TEST
Chemistry
31d
Cleared
Jun 15, 1979
ABUSCREEN RIA FOR PHENCYCLIDINE
Toxicology
71d
Cleared
May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
Chemistry
52d
Cleared
Apr 04, 1979
CPK-CS
Chemistry
40d
Cleared
Mar 21, 1979
SENSI-TEX
Chemistry
43d
Cleared
Aug 31, 1978
ENTEROTUBE II
Microbiology
42d
Cleared
Mar 30, 1978
ROCHE TSH RIA
Chemistry
13d
Cleared
Sep 20, 1977
T3 RIA
Toxicology
26d
Cleared
Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
Immunology
48d
Cleared
Jul 20, 1976
TEST, IN-VITRO DIAGNOSTIC
Immunology
29d