GENTIAN CYSTATIN C IMMUNOASSAY

Device Classification Name

test, cystatin c

510(k) Number K071388
Device Name GENTIAN CYSTATIN C IMMUNOASSAY
Applicant
GENTIAN AS
9915 cam. chirimolla
san diego, 
CA 
92131

Applicant Contact ronald g leonardi
Correspondent
GENTIAN AS
9915 cam. chirimolla
san diego, 
CA 
92131

Correspodent Contact ronald g leonardi
Regulation Number 862.1225
Classification Product Code
NDY  
Date Received 05/18/2007
Decision Date 11/06/2007
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