Syva Co. - FDA 510(k) Cleared Devices
448
Total
447
Cleared
0
Denied
97 devices
Cleared
Jun 16, 1989
MICROTRAK EIA AUTOREADER
Chemistry
99d
Cleared
Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
Chemistry
52d
Cleared
Mar 31, 1989
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
Chemistry
98d
Cleared
Feb 17, 1989
EMIT THYROXINE ASSAY
Chemistry
64d
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 18, 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
Chemistry
62d
Cleared
Mar 24, 1988
EMIT THYROXINE ASSAY
Chemistry
37d
Cleared
Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
Chemistry
18d
Cleared
Jul 16, 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
Chemistry
44d
Cleared
May 26, 1987
SYVA Q-SPEC PHOTOMETER
Chemistry
55d
Cleared
Mar 13, 1987
SYVA ETS SYSTEM
Chemistry
203d
Cleared
Jun 13, 1986
SYVA SOLID PHASE COLUMNS SYSTEM II
Chemistry
60d
Cleared
May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
Chemistry
45d
Cleared
May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
Chemistry
45d
Cleared
May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
Chemistry
23d
Cleared
Aug 29, 1985
SYVA SOLID PHASE COLUMNS
Chemistry
252d
Cleared
Aug 12, 1983
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS
Chemistry
44d
Cleared
Aug 11, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESSENT
Chemistry
52d
Cleared
Aug 11, 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
Chemistry
43d
Cleared
Aug 08, 1983
EMIT ASSAY AND TOBRAMYCIN
Chemistry
42d
Cleared
Aug 08, 1983
EMIT AMD GENTAMICIN ASSAY
Chemistry
42d
Cleared
Aug 08, 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
Chemistry
40d
Cleared
Aug 01, 1983
EMIT AED PHENYTOIN ASSAY
Chemistry
39d
Cleared
Aug 01, 1983
EMIT AAD THEOPHYLLINE ASSAY
Chemistry
39d
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