Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
307 devices
Cleared
Jan 06, 1994
EMIT(R) IIC OPIATE ASSAY
Toxicology
71d
Cleared
Jan 03, 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
Toxicology
63d
Cleared
Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
Toxicology
119d
Cleared
Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
Toxicology
154d
Cleared
Jun 15, 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
Toxicology
78d
Cleared
May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
Toxicology
43d
Cleared
Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
Toxicology
42d
Cleared
Jan 12, 1993
EMIT(R) II BARBITURATE ASSAY
Toxicology
42d
Cleared
Nov 02, 1992
SYVA EMIT II PROPOXYPHENE ASSAY
Toxicology
91d
Cleared
Aug 24, 1992
EMIT 2000 PROCAINAMIDE CALIBRATORS
Toxicology
68d
Cleared
Aug 24, 1992
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
Toxicology
68d
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
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 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 22, 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
Toxicology
32d
Cleared
Mar 14, 1991
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
Toxicology
35d
Cleared
Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
Toxicology
24d
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