FDA 510(k) Application Details - K051108

Device Classification Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase   More FDA Info for this Device
510(K) Number	K051108
Device Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Applicant	ABAXIS, INC. 3240 WHIPPLE RD. UNION CITY, CA 94587 US Other 510(k) Applications for this Company
Contact	Dennis M Bleile 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	05/02/2005
Decision Date	07/08/2005
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