FDA 510(k) Application Details - K963197

Device Classification Name	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method   More FDA Info for this Device
510(K) Number	K963197
Device Name	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Applicant	ANSYS, INC. 2 GOODYEAR IRVINE, CA 92618-2054 US Other 510(k) Applications for this Company
Contact	LORNA GAMBOA Other 510(k) Applications for this Contact
Regulation Number	862.3040   More FDA Info for this Regulation Number
Classification Product Code	DML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1996
Decision Date	09/19/1996
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