FDA 510(k) Application Details - K200210

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K200210
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	Siemens Healthcare Diagnostics, 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	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2020
Decision Date	07/13/2021
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