FDA 510(k) Application Details - K062737

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K062737
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE MONTPELLIER, HERAULT 34184 FR Other 510(k) Applications for this Company
Contact	TIM LAWTON 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	09/13/2006
Decision Date	06/12/2007
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