FDA 510(k) Application Details - K212648

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K212648
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	Ortho Clinical Diagnostics Felindre Meadows Pencoed CF35 5PZ GB Other 510(k) Applications for this Company
Contact	Declan Hynes 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	08/23/2021
Decision Date	01/28/2022
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