FDA 510(k) Application Details - K163658

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K163658
Device Name	Radioimmunoassay, Parathyroid Hormone
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	862.1545   More FDA Info for this Regulation Number
Classification Product Code	CEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2016
Decision Date	05/23/2017
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