FDA 510(k) Application Details - K971506

Device Classification Name	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet   More FDA Info for this Device
510(K) Number	K971506
Device Name	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
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	862.3040   More FDA Info for this Regulation Number
Classification Product Code	DMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/1997
Decision Date	06/03/1997
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