LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT


Device Classification Name

radioimmunoassay, angiotensin i and renin

510(k) Number K121944
Device Name LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
Applicant
DIASORIN, INC.
1951 northwestern ave.
stillwater, 
MN 
55082 -0285

Applicant Contact mari meyer
Correspondent
DIASORIN, INC.
1951 northwestern ave.
stillwater, 
MN 
55082 -0285

Correspodent Contact mari meyer
Regulation Number 862.1085
Classification Product Code
CIB  
Subsequent Product Code
JJX  
Date Received 07/03/2012
Decision Date 01/01/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No