Device Classification Name |
Ferritin, Antigen, Antiserum, Control
|
510(k) Number |
K030124 |
Device Name |
OLYMPUS FERRITIN REAGENT |
Applicant |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Applicant Contact |
MICHAEL CAMPBELL |
Correspondent |
OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. |
IRVING,
TX
75063 -3104
|
|
Correspondent Contact |
MICHAEL CAMPBELL |
Regulation Number | 866.5340
|
Classification Product Code |
|
Date Received | 01/14/2003 |
Decision Date | 02/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|