Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
448 devices
Cleared
Jul 08, 1988
EMIT HVA CONTROL KIT
Toxicology
60d
Cleared
Jul 01, 1988
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
Toxicology
29d
Cleared
Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
Chemistry
38d
Cleared
May 27, 1988
EMIT CONVENIENCE PACK: THYROXINE ASSAY
Chemistry
57d
Cleared
Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
Microbiology
85d
Cleared
Apr 19, 1988
EMIT VANCOMYCIN ASSAY
Toxicology
39d
Cleared
Apr 18, 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
Chemistry
62d
Cleared
Apr 05, 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
Toxicology
113d
Cleared
Mar 24, 1988
EMIT THYROXINE ASSAY
Chemistry
37d
Cleared
Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
Microbiology
16d
Cleared
Feb 04, 1988
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
Microbiology
22d
Cleared
Jan 11, 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
Toxicology
62d
Cleared
Jan 05, 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
Toxicology
50d
Cleared
Jan 05, 1988
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
Toxicology
41d
Cleared
Dec 22, 1987
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
Toxicology
42d
Cleared
Dec 18, 1987
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
Toxicology
32d
Cleared
Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
Chemistry
18d
Cleared
Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
Toxicology
28d
Cleared
Nov 13, 1987
EMIT TOBRAMYCIN ASSAY
Toxicology
28d
Cleared
Oct 29, 1987
EMIT QST GENTAMICIN ASSAY
Toxicology
37d
Cleared
Oct 29, 1987
REVISED LABELING FOR SYVA OPIATE ASSAYS
Toxicology
35d
Cleared
Oct 29, 1987
REVISED LABELING FOR SYVA AMPHETAMINE ASSAY
Toxicology
23d
Cleared
Oct 28, 1987
EMIT GENTAMICIN ASSAY
Toxicology
36d
Cleared
Oct 28, 1987
REVISED LABELING FOR SYVA METHADONE ASSAYS
Toxicology
34d
Cleared
Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
Toxicology
22d
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