LEG · Class II · 21 CFR 862.3645

FDA Product Code LEG: Enzyme Immunoassay, Valproic Acid

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Dade Behring, Inc..

35
Total
35
Cleared
80d
Avg days
1980
Since
35 devices
25–35 of 35
Cleared Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581
Roche Diagnostic Systems, Inc.
Toxicology · 148d
Cleared Jul 29, 1986
EMIT VALPROIC ACID ASSAY
K862652
Syva Co.
Toxicology · 18d
Cleared Oct 04, 1983
EMIT AED VALPROIC ACID ASSAY
K832719
Syva Co.
Toxicology · 53d
Cleared Apr 12, 1983
AMES TDA VALPROIC ACID TEST
K830789
Miles Laboratories, Inc.
Chemistry · 29d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933
Syva Co.
Chemistry · 23d
Cleared Jan 28, 1981
CYBREX VALPROIC ACID
K803236
Abbott Laboratories
Toxicology · 36d
Cleared Jun 20, 1980
EMIT VALPROIC ACID ASSAY
K801207
Syva Co.
Toxicology · 32d