FDA 510(k) Application Details - K062120

Device Classification Name	Radioimmunoassay, Angiotensin I And Renin   More FDA Info for this Device
510(K) Number	K062120
Device Name	Radioimmunoassay, Angiotensin I And Renin
Applicant	CIS BIO INTERNATIONAL 150 CHERRY LANE ROAD EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus 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	07/25/2006
Decision Date	03/30/2007
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