The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite Ch50 Reagent, Optilite Ch50 Controls And Optilite Ch50 Calibrator.
| Device ID | K150412 |
| 510k Number | K150412 |
| Device Name: | Optilite CH50 Reagent, Optilite CH50 Controls And Optilite CH50 Calibrator |
| Classification | Complement C9, Antigen, Antiserum, Control |
| Applicant | The Binding Site Group Ltd 8 Calthorpe Road, Edgbaston, GB B15 1qt |
| Contact | Marianne Sender |
| Correspondent | Marianne Sender The Binding Site Group Ltd 8 Calthorpe Road, Edgbaston, GB B15 1qt |
| Product Code | DAE |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700018227 | K150412 | 000 |
| 05051700018210 | K150412 | 000 |
| 05051700018203 | K150412 | 000 |