FDA 510(k) Application Details - K000410

Device Classification Name	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet   More FDA Info for this Device
510(K) Number	K000410
Device Name	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Applicant	BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 BREA, CA 92822-8000 US Other 510(k) Applications for this Company
Contact	LUCINDA STOCKERT 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	02/08/2000
Decision Date	04/10/2000
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