Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
448 devices
Cleared
Jun 10, 1991
SYVA EDMS
Chemistry
32d
Cleared
Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
Toxicology
35d
Cleared
Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
Microbiology
113d
Cleared
Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
Toxicology
24d
Cleared
Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
Toxicology
90d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 100 NG ASSAY
Toxicology
78d
Cleared
Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
Toxicology
78d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
Toxicology
78d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
Toxicology
78d
Cleared
Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
Toxicology
37d
Cleared
Nov 20, 1990
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
Toxicology
29d
Cleared
Sep 27, 1990
SYVA(R) ETS(R) PLUS SYSTEM
Chemistry
63d
Cleared
Sep 12, 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
Microbiology
23d
Cleared
Aug 17, 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
Toxicology
30d
Cleared
Aug 17, 1990
EMIT ETS PLUS ETHYL ALCOHOL ASSAY
Toxicology
25d
Cleared
Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
Toxicology
22d
Cleared
Jul 27, 1990
EMIT(R) II OPIATE ASSAY
Toxicology
46d
Cleared
Jul 27, 1990
EMIT(R) II COCAINE METABOLITE ASSAY
Toxicology
46d
Cleared
Jul 27, 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
Toxicology
46d
Cleared
Jul 19, 1990
EMIT(R) II BARBITURATE ASSAY
Toxicology
38d
Cleared
Jul 10, 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
Toxicology
29d
Cleared
Jun 06, 1990
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
Toxicology
63d
Cleared
Apr 20, 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
Toxicology
50d
Cleared
Jan 18, 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
Toxicology
23d
Cleared
Jan 17, 1990
PFEIFFER METERED DOSAGE SYSTEM
Anesthesiology
90d
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