FDA 510(k) Application Details - K083465

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K083465
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	VICTOR M CARRIO 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	11/24/2008
Decision Date	02/27/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review