FDA 510(k) Application Details - K090358

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K090358
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP6C-2; DEPT 049C ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	JUDI WALLACH 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	02/12/2009
Decision Date	08/06/2009
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