FDA 510(k) Application Details - K955644

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K955644
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	BECKMAN INSTRUMENTS, INC. 200 S. KRAEMER BLVD., W-337 BREA, CA 92622-8000 US Other 510(k) Applications for this Company
Contact	SHERI HALL Other 510(k) Applications for this Contact
Regulation Number	862.3645   More FDA Info for this Regulation Number
Classification Product Code	KLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1995
Decision Date	02/16/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review