Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
Toxicology
55d
Cleared
Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
Toxicology
55d
Cleared
Jul 06, 1993
ROCHE CARDIOTROL-CK
Chemistry
134d
Cleared
May 26, 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
Chemistry
154d
Cleared
May 26, 1993
COBAS CORE LH EIA
Chemistry
125d
Cleared
May 20, 1993
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
Chemistry
148d
Cleared
Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
Toxicology
61d
Cleared
Apr 05, 1993
ROCHE OXI/FERM II
Microbiology
272d
Cleared
Feb 25, 1993
COBAS-FP TDM CONTROLS
Toxicology
37d
Cleared
Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
Chemistry
231d
Cleared
Jan 04, 1993
ROCHE REAGENT FOR AST
Chemistry
133d
Cleared
Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
Toxicology
137d
Cleared
Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
Toxicology
62d
Cleared
Nov 18, 1992
ROCHE REAGENT FOR GGT
Chemistry
86d
Cleared
Oct 22, 1992
ROCHE REAGENT FOR ALT
Chemistry
59d
Cleared
Sep 11, 1992
ROCHE ENTEROTUBE II
Microbiology
102d
Cleared
Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
Toxicology
40d
Cleared
Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
Chemistry
140d
Cleared
Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
Chemistry
51d
Cleared
Jun 19, 1992
COBAS CORE FERRITIN EIA
Immunology
116d
Cleared
Jun 16, 1992
ROCHE CALIBRATOR SERUM
Chemistry
46d
Cleared
May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
Toxicology
33d
Cleared
Apr 29, 1992
ROCHE COBAS MIRA PLUS
Chemistry
89d
Cleared
Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
Toxicology
19d
Cleared
Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
Toxicology
50d
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