Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
448 devices
Cleared
Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
Toxicology
475d
Cleared
Feb 22, 1995
EMIT(R) IIC AMPHETAMINE ASSAY
Toxicology
474d
Cleared
Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
Toxicology
406d
Cleared
Nov 15, 1994
EMIT 2000 DIGOXIN ASSAY
Toxicology
133d
Cleared
Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
Chemistry
117d
Cleared
Aug 15, 1994
VISTA B12 ASSAY
Chemistry
153d
Cleared
Apr 06, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
Toxicology
224d
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 22, 1993
VISTA FOLATE ASSAY
Chemistry
58d
Cleared
Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
Toxicology
119d
Cleared
Sep 30, 1993
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
Microbiology
302d
Cleared
Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
Toxicology
154d
Cleared
Aug 05, 1993
VISTA FERRITIN ASSAY
Immunology
128d
Cleared
Jun 15, 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
Toxicology
78d
Cleared
Jun 02, 1993
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
Hematology
161d
Cleared
May 26, 1993
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
Chemistry
156d
Cleared
May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
Toxicology
43d
Cleared
Mar 29, 1993
VISTA PROLACTIN ASSAY
Chemistry
97d
Cleared
Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
Chemistry
62d
Cleared
Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
Toxicology
42d
Cleared
Jan 12, 1993
EMIT(R) II BARBITURATE ASSAY
Toxicology
42d
Cleared
Nov 16, 1992
VISTA FREE THYROXINE ASSAY
Chemistry
122d
Cleared
Nov 02, 1992
SYVA EMIT II PROPOXYPHENE ASSAY
Toxicology
91d
Cleared
Oct 15, 1992
VISTA TRIIODOTHYRONINE ASSAY
Chemistry
90d
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