FDA 510(k) Application Details - K980900

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K980900
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	CRESTAT DIAGNOSTICS, INC. 910 INDUSTRY DR. SEATTLE, WA 98056 US Other 510(k) Applications for this Company
Contact	COLIN GETTY 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	03/10/1998
Decision Date	03/26/1998
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