Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
118 devices
Cleared
Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
Chemistry
93d
Cleared
Oct 31, 1994
ROCHE REAGENT
Chemistry
214d
Cleared
Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
Chemistry
159d
Cleared
Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
Chemistry
122d
Cleared
Aug 26, 1994
ROCHE REAGENT FOR CREATININE
Chemistry
135d
Cleared
Jan 24, 1994
COBAS (R) CORE T4 EIA
Chemistry
241d
Cleared
Jan 24, 1994
COBAS(R) CORE FT4 EIA
Chemistry
241d
Cleared
Dec 03, 1993
COBAS CORE TSH EIA
Chemistry
290d
Cleared
Dec 03, 1993
COBAS(R) CORE T3 EIA
Chemistry
189d
Cleared
Sep 21, 1993
COBAS CORE FSH EIA
Chemistry
243d
Cleared
Aug 19, 1993
COBAS CORE PROLACTIN EIA
Chemistry
210d
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
Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
Chemistry
231d
Cleared
Jan 04, 1993
ROCHE REAGENT FOR AST
Chemistry
133d
Cleared
Nov 18, 1992
ROCHE REAGENT FOR GGT
Chemistry
86d
Cleared
Oct 22, 1992
ROCHE REAGENT FOR ALT
Chemistry
59d
Cleared
Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
Chemistry
140d
Cleared
Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
Chemistry
51d
Cleared
Jun 16, 1992
ROCHE CALIBRATOR SERUM
Chemistry
46d
Cleared
Apr 29, 1992
ROCHE COBAS MIRA PLUS
Chemistry
89d
Cleared
Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
Chemistry
31d
Cleared
Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
Chemistry
28d
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