GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR


Device Classification Name

test, cystatin c

510(k) Number K080662
Device Name GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
Applicant
GENZYME CORPORATION
31 new york avenue
framingham, 
MA 
01701 -9322

Applicant Contact eric lawson
Correspondent
GENZYME CORPORATION
31 new york avenue
framingham, 
MA 
01701 -9322

Correspodent Contact eric lawson
Regulation Number 862.1225
Classification Product Code
NDY  
Subsequent Product Code
JIT  
Date Received 03/10/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No