The following data is part of a premarket notification filed by The Binding Site Group Ltd. with the FDA for Optilite C-reactive Protein Reagent,optilite C-reactive Protein Calibrator,optilite C-reactive Protein Controls.
| Device ID | K172868 |
| 510k Number | K172868 |
| Device Name: | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls |
| Classification | System, Test, C-reactive Protein |
| Applicant | The Binding Site Group Ltd. 8 Calthorpe Road, Edgbaston Birmingham, GB B15 1qt |
| Contact | Kirsty Samuels |
| Correspondent | Kirsty Samuels The Binding Site Group Ltd. 8 Calthorpe Road, Edgbaston Birmingham, GB B15 1qt |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2018-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700020091 | K172868 | 000 |
| 05051700020084 | K172868 | 000 |
| 05051700018449 | K172868 | 000 |