FDA 510(k) Application Details - K973069

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K973069
Device Name	Enzyme Immunoassay, Methadone
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 BREA, CA 92821-6208 US Other 510(k) Applications for this Company
Contact	LUCINDA STOCKERT Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/1997
Decision Date	09/22/1997
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