FDA 510(k) Application Details - K142994

Device Classification Name	Radioimmunoassay, Aldosterone   More FDA Info for this Device
510(K) Number	K142994
Device Name	Radioimmunoassay, Aldosterone
Applicant	IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD GB Other 510(k) Applications for this Company
Contact	Mick Fenton Other 510(k) Applications for this Contact
Regulation Number	862.1045   More FDA Info for this Regulation Number
Classification Product Code	CJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2014
Decision Date	04/21/2015
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