K180099 is an FDA 510(k) clearance for the Optilite High Sensitivity C-Reactive Protein Kit. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on October 12, 2018, 269 days after receiving the submission on January 16, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K180099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2018 |
| Decision Date | October 12, 2018 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |