FDA 510(k) Application Details - K961988

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K961988
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. SUNNYVALE, CA 94086 US Other 510(k) Applications for this Company
Contact	YUG-GENG TSAY, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.3645   More FDA Info for this Regulation Number
Classification Product Code	LEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/1996
Decision Date	07/16/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review