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
|
|
Correspondent Contact |
DAVIDE SPADA |
Regulation Number | 866.5210
|
Classification Product Code |
|
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
|
|
|