FDA 510(k) Application Details - K955675

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K955675
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 BREA, CA 92821-6208 US Other 510(k) Applications for this Company
Contact	SHERI HALL Other 510(k) Applications for this Contact
Regulation Number	862.3700   More FDA Info for this Regulation Number
Classification Product Code	JXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/1995
Decision Date	02/09/1996
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