FDA 510(k) Application Details - K082226

Device Classification Name	Differential Rate Kinetic Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K082226
Device Name	Differential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant	ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	DENNIS TASCHEK Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2008
Decision Date	09/18/2008
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