K160070 is an FDA 510(k) clearance for the Rheumatoid Factor (RF) Kit for use on SPAPLUS. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on December 7, 2016, 329 days after receiving the submission on January 13, 2016.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K160070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2016 |
| Decision Date | December 07, 2016 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |