Device Classification Name |
method, nephelometric, immunoglobulins (g, a, m)
|
510(k) Number |
K191985 |
Device Name |
Optilite IgA Kit |
Applicant |
The Binding Site Group Ltd. |
8 Calthorpe Road |
Edgbaston,
GB
B15 1QT
|
|
Applicant Contact |
Natasha Verhaak |
Correspondent |
The Binding Site Group Ltd. |
8 Calthorpe Road |
Edgbaston,
GB
B15 1QT
|
|
Correspondent Contact |
Natasha Verhaak |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 07/25/2019 |
Decision Date | 08/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|