FDA 510(k) Application Details - K010960

Device Classification Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method   More FDA Info for this Device
510(K) Number	K010960
Device Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Applicant	SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD SAN JOSE, CA 95135 US Other 510(k) Applications for this Company
Contact	SUSAN COLLINS Other 510(k) Applications for this Contact
Regulation Number	862.3040   More FDA Info for this Regulation Number
Classification Product Code	DIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2001
Decision Date	04/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review