FDA 510(k) Application Details - K974001

Device Classification Name	Nadh Oxidation/Nad Reduction, Ast/Sgot   More FDA Info for this Device
510(K) Number	K974001
Device Name	Nadh Oxidation/Nad Reduction, Ast/Sgot
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	862.1100   More FDA Info for this Regulation Number
Classification Product Code	CIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/1997
Decision Date	11/13/1997
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