FDA 510(k) Application Details - K011128

Device Classification Name	Radioimmunoassay, Angiotensin I And Renin   More FDA Info for this Device
510(K) Number	K011128
Device Name	Radioimmunoassay, Angiotensin I And Renin
Applicant	NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	JIMMY WONG 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	04/13/2001
Decision Date	09/06/2001
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