FDA 510(k) Application Details - K971566

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K971566
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	HORIZON DIAGNOSTICS, INC. 3660 PLAZA DRIVE,STE.4 ANN ARBOR, MI 48108 US Other 510(k) Applications for this Company
Contact	DAVID L CALLENDER Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	CGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/1997
Decision Date	07/14/1997
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