Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
448 devices
Cleared
Oct 09, 1992
VISTA THYROXINE UPTAKE ASSAY
Chemistry
79d
Cleared
Oct 01, 1992
MICRO TRAK XL SYSTEM
Microbiology
171d
Cleared
Sep 25, 1992
SYVA MICROTRAK CHLAMYDIA EIA
Microbiology
233d
Cleared
Sep 25, 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
Microbiology
182d
Cleared
Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
Chemistry
155d
Cleared
Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
Chemistry
68d
Cleared
Aug 24, 1992
EMIT 2000 PROCAINAMIDE CALIBRATORS
Toxicology
68d
Cleared
Aug 24, 1992
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
Toxicology
68d
Cleared
Jul 21, 1992
VISTA ULTRASENSITIVE HTSH ASSAY
Chemistry
96d
Cleared
Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
Chemistry
96d
Cleared
May 13, 1992
SYVA EMIT II METHAQUALONE ASSAY
Toxicology
71d
Cleared
Mar 13, 1992
SYVA EMIT II METHADONE ASSAY
Toxicology
23d
Cleared
Feb 27, 1992
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
Toxicology
22d
Cleared
Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
Toxicology
71d
Cleared
Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
Chemistry
38d
Cleared
Nov 29, 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
Toxicology
23d
Cleared
Nov 29, 1991
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
Toxicology
22d
Cleared
Sep 30, 1991
MICROTAK PLUS
Chemistry
35d
Cleared
Sep 19, 1991
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
Toxicology
66d
Cleared
Sep 16, 1991
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
Toxicology
47d
Cleared
Aug 26, 1991
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
Toxicology
39d
Cleared
Aug 26, 1991
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
Toxicology
25d
Cleared
Jul 30, 1991
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
Toxicology
20d
Cleared
Jul 26, 1991
MICROTRAK MANAGER
Chemistry
18d
Cleared
Jul 22, 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
Toxicology
32d
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