FDA 510(k) Application Details - K123763

Device Classification Name	Radioimmunoassay, Angiotensin I And Renin   More FDA Info for this Device
510(K) Number	K123763
Device Name	Radioimmunoassay, Angiotensin I And Renin
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	862.1085   More FDA Info for this Regulation Number
Classification Product Code	CIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2012
Decision Date	12/24/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review