FDA 510(k) Application Details - K220977

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K220977
Device Name	Electrode, Ion Specific, Sodium
Applicant	Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. No. 181 West Su Hong Road, Suzhou Industrial Park Suzhou 215021 CN Other 510(k) Applications for this Company
Contact	Tracy Jin Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	JGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2022
Decision Date	07/20/2023
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