FDA 510(k) Application Details - K223921

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K223921
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	Beckman Coulter, Inc 1000 Lake Hazeltine Drive Chaska, MN 55318 US Other 510(k) Applications for this Company
Contact	Abhi Kannan Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	DHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2022
Decision Date	09/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review