FDA 510(k) Application Details - K121981

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K121981
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict Avenue Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	PHILIP LIU 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	07/06/2012
Decision Date	03/21/2013
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