FDA 510(k) Application Details - K031870

Device Classification Name	Enzyme Immunoassay, Valproic Acid   More FDA Info for this Device
510(K) Number	K031870
Device Name	Enzyme Immunoassay, Valproic Acid
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	MARY BETH TANG 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	06/17/2003
Decision Date	07/15/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review