FDA 510(k) Application Details - K163462

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K163462
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	Radiometer Medical ApS Aakandevej 21 Broenshoej 2700 DK Other 510(k) Applications for this Company
Contact	Per Pape Thomsen 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	12/09/2016
Decision Date	09/21/2017
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