FDA 510(k) Application Details - K994189

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K994189
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. MELVILLE, NY 11747 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER 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	12/13/1999
Decision Date	01/20/2000
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