The following data is part of a premarket notification filed by The Binding Site Group with the FDA for C-reactive Protein Kit For Use On Spaplus.
| Device ID | K161982 |
| 510k Number | K161982 |
| Device Name: | C-Reactive Protein Kit For Use On SPAPLUS |
| Classification | System, Test, C-reactive Protein |
| Applicant | THE BINDING SITE GROUP 8 CALTHORPE ROAD, EDGBASTON Birmingham, GB B15 1qt |
| Contact | Kirsty Samuels |
| Correspondent | Kirsty Samuels THE BINDING SITE GROUP 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 | 2016-07-19 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700018456 | K161982 | 000 |