Device Classification Name |
Ferritin, Antigen, Antiserum, Control
|
510(k) Number |
K121232 |
Device Name |
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR |
Applicant |
KAMIYA BIOMEDICAL COMPANY |
12779 GATEWAY DR |
SEATTLE,
WA
98168
|
|
Applicant Contact |
SHAWN KAPLAN |
Correspondent |
KAMIYA BIOMEDICAL COMPANY |
12779 GATEWAY DR |
SEATTLE,
WA
98168
|
|
Correspondent Contact |
SHAWN KAPLAN |
Regulation Number | 866.5340
|
Classification Product Code |
|
Date Received | 04/24/2012 |
Decision Date | 05/24/2012 |
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
|
|
|