The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite Freelite Kappa Free Kit, Optilite Freelite Lambda Free Kit.
| Device ID | K150658 |
| 510k Number | K150658 |
| Device Name: | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, Birmingham, GB B15 1qt |
| Contact | Andrea Thomas |
| Correspondent | Andrea Thomas THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, 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 | 2015-03-13 |
| Decision Date | 2015-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700019675 | K150658 | 000 |
| 05051700019651 | K150658 | 000 |
| 05051700017800 | K150658 | 000 |
| 05051700017794 | K150658 | 000 |