FDA 510(k) Application Details - K974859

Device Classification Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase   More FDA Info for this Device
510(K) Number	K974859
Device Name	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Applicant	DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK 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	12/29/1997
Decision Date	01/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review