SENTINEL CERULOPLASMIN


Device Classification Name

indirect copper assay, ceruloplasmin

510(k) Number K051456
Device Name SENTINEL CERULOPLASMIN
Applicant
SENTINEL CH. SRL
5 via principe eugenio
milano, 

IT

20155

Applicant Contact davide spada
Correspondent
SENTINEL CH. SRL
5 via principe eugenio
milano, 

IT

20155

Correspodent Contact davide spada
Regulation Number 866.5210
Classification Product Code
JFR  
Date Received 06/02/2005
Decision Date 10/21/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No