The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit.
| Device ID | K173732 |
| 510k Number | K173732 |
| Device Name: | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | The Binding Site Group Ltd 8 Calthorpe Road Edgbaston Birmingham, GB B15 1qt |
| Contact | Christopher Bradshaw |
| Correspondent | Andrea Thomas The Binding Site Group Ltd 8 Calthorpe Road Edgbaston Birmingham, GB B15 1qt |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-06 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700019873 | K173732 | 000 |
| 05051700019866 | K173732 | 000 |