The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Human Iga Liquid Reagent Kit For Use On Spaplus.
| Device ID | K192116 |
| 510k Number | K192116 |
| Device Name: | Human IgA Liquid Reagent Kit For Use On SPAPlus |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | The Binding Site Group Ltd 8 Calthorpe Road Edgbaston Birmingham, GB B15 1qt |
| Contact | Natasha Verhaak |
| Correspondent | Natasha Verhaak The Binding Site Group Ltd 8 Calthorpe Road Edgbaston Birmingham, GB B15 1qt |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-09-04 |
| Summary: | summary |