The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite Hevylite Igm Kappa Kit; Optilite Hevylite Igm Lambda Kit.
| Device ID | K152389 |
| 510k Number | K152389 |
| Device Name: | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit |
| Classification | Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE RD EDGBASTON Birmingham, GB B15 1qt |
| Contact | Stephanie Thouless |
| Correspondent | Stephanie Thouless THE BINDING SITE GROUP LTD 8 CALTHORPE RD EDGBASTON Birmingham, GB B15 1qt |
| Product Code | PDE |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2015-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700018364 | K152389 | 000 |
| 05051700018357 | K152389 | 000 |