FDA 510(k) Application Details - K023744

Device Classification Name	U.V. Method, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K023744
Device Name	U.V. Method, Cpk Isoenzymes
Applicant	WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA ROSARIO 2000 AR Other 510(k) Applications for this Company
Contact	VIVIANA CETOLA 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	11/07/2002
Decision Date	01/03/2003
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