MULTIGENT CREATININE (ENZYMATIC) ASSAY


Device Classification Name

enzymatic method, creatinine

510(k) Number K073634
Device Name MULTIGENT CREATININE (ENZYMATIC) ASSAY
Applicant
SENTINEL CH. SpA
via robert koch, 2
milano, 

IT

20152

Applicant Contact fabio rota
Correspondent
SENTINEL CH. SpA
via robert koch, 2
milano, 

IT

20152

Correspodent Contact fabio rota
Regulation Number 862.1225
Classification Product Code
JFY  
Date Received 12/26/2007
Decision Date 06/19/2008
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