FDA 510(k) Application Details - K003158

Device Classification Name	U.V. Method, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K003158
Device Name	U.V. Method, Cpk Isoenzymes
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	KAY A TALOR Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2000
Decision Date	12/18/2000
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