FDA 510(k) Application Details - K982880

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K982880
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	REBECCA S AYASH 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	08/14/1998
Decision Date	08/25/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review