Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
|
510(k) Number |
K192116 |
Device Name |
Human IgA liquid reagent kit for Use on SPAPlus |
Applicant |
The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston |
Birmingham,
GB
B15 1QT
|
|
Applicant Contact |
Natasha Verhaak |
Correspondent |
The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston |
Birmingham,
GB
B15 1QT
|
|
Correspondent Contact |
Natasha Verhaak |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 08/06/2019 |
Decision Date | 09/04/2019 |
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
|
|
|