FDA 510(k) Application Details - K955676

Device Classification Name	Radioimmunoassay, Methaqualone   More FDA Info for this Device
510(K) Number	K955676
Device Name	Radioimmunoassay, Methaqualone
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	862.3630   More FDA Info for this Regulation Number
Classification Product Code	KXS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/1995
Decision Date	03/04/1996
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