FDA 510(k) Application Details - K060690

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K060690
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	DIMITRIS DEMIRTZOGLOU 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	03/15/2006
Decision Date	08/08/2006
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