FDA 510(k) Application Details - K002551

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K002551
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	DADE BEHRING, INC. 3403 YERBA BUENA RD. SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	PAUL L ROGERS 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	08/17/2000
Decision Date	10/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review