The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite High Sensitivity C-reactive Protein Kit.
| Device ID | K180099 |
| 510k Number | K180099 |
| Device Name: | Optilite High Sensitivity C-Reactive Protein Kit |
| Classification | System, Test, C-reactive Protein |
| Applicant | The Binding Site Group Ltd 8 Calthorpe Road, Edgbaston West Midlands Birmingham, GB B15 1qt |
| Contact | Kirsty Samuels |
| Correspondent | Andrea Thomas The Binding Site Group Ltd 8 Calthorpe Road, Edgbaston West Midlands 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 | 2018-01-16 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700020152 | K180099 | 000 |