FDA 510(k) Application Details - K161158

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K161158
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	IMMUNODIAGNOSTIC SYSTEMS LTD 10 DIDCOT WAY BOLDON BUSINESS PARK BOLDON Ne35 9pd GB Other 510(k) Applications for this Company
Contact	CHRIS PRICE 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	04/25/2016
Decision Date	01/31/2017
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