FDA 510(k) Application Details - K182072

Device Classification Name	Electrode, Ion-Specific, Chloride   More FDA Info for this Device
510(K) Number	K182072
Device Name	Electrode, Ion-Specific, Chloride
Applicant	Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 US Other 510(k) Applications for this Company
Contact	Marlene Hanna Other 510(k) Applications for this Contact
Regulation Number	862.1170   More FDA Info for this Regulation Number
Classification Product Code	CGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2018
Decision Date	10/30/2018
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