FDA 510(k) Application Details - K013912

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K013912
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	JAS Diagnostics, Inc. 7220 NW 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston 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	11/27/2001
Decision Date	01/18/2002
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