FDA 510(k) Application Details - K112416

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K112416
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD 189-199 BROWNS ROAD NOBLE PARK, VICTORIA 3174 AU Other 510(k) Applications for this Company
Contact	MELITA LAMBIRIS 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	08/22/2011
Decision Date	11/09/2011
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