HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER


Device Classification Name

test, cystatin c

510(k) Number K080384
Device Name HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
Applicant
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Applicant Contact jay h geller
Correspondent
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Correspodent Contact jay h geller
Regulation Number 862.1225
Classification Product Code
NDY  
Date Received 02/13/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No