FDA 510(k) Application Details - K091544

Device Classification Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase   More FDA Info for this Device
510(K) Number	K091544
Device Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Applicant	ALFA WASSERMANN, INC. 4 HENDERSON DR. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ Other 510(k) Applications for this Contact
Regulation Number	862.1440   More FDA Info for this Regulation Number
Classification Product Code	CFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2009
Decision Date	09/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review