FDA 510(k) Application Details - K172201

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K172201
Device Name	Acid, Folic, Radioimmunoassay
Applicant	Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Darius Daruwala Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2017
Decision Date	04/12/2018
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