FDA 510(k) Application Details - K200215

Device Classification Name	System, Test, Carcinoembryonic Antigen   More FDA Info for this Device
510(K) Number	K200215
Device Name	System, Test, Carcinoembryonic Antigen
Applicant	Siemens Healthcare Disgnostics Inc. 511 Benedict Ave. Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Mey Lyn Vasquez 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	01/28/2020
Decision Date	04/13/2020
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