FDA 510(k) Application Details - K120326

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K120326
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	OLE SCHOU Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2012
Decision Date	11/21/2012
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