Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
Chemistry
122d
Cleared
Aug 26, 1994
ROCHE REAGENT FOR CREATININE
Chemistry
135d
Cleared
Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
Toxicology
293d
Cleared
Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
Toxicology
104d
Cleared
Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
Toxicology
68d
Cleared
Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
Toxicology
78d
Cleared
Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
Toxicology
78d
Cleared
Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
Toxicology
343d
Cleared
Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
Toxicology
96d
Cleared
Jan 24, 1994
COBAS (R) CORE T4 EIA
Chemistry
241d
Cleared
Jan 24, 1994
COBAS(R) CORE FT4 EIA
Chemistry
241d
Cleared
Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
Toxicology
47d
Cleared
Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
Toxicology
217d
Cleared
Dec 03, 1993
COBAS CORE TSH EIA
Chemistry
290d
Cleared
Dec 03, 1993
COBAS(R) CORE T3 EIA
Chemistry
189d
Cleared
Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
Toxicology
213d
Cleared
Sep 21, 1993
COBAS CORE FSH EIA
Chemistry
243d
Cleared
Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
Toxicology
112d
Cleared
Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
Toxicology
96d
Cleared
Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
Toxicology
92d
Cleared
Aug 19, 1993
COBAS CORE PROLACTIN EIA
Chemistry
210d
Cleared
Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
Toxicology
34d
Cleared
Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
Immunology
164d
Cleared
Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
Toxicology
152d
Cleared
Aug 03, 1993
ABUSCREEN ONLINE CONTROL
Toxicology
152d
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