K201256 is an FDA 510(k) clearance for the Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Procise Diagnostics (San Diego, US). The FDA issued a Cleared decision on November 4, 2022, 907 days after receiving the submission on May 11, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K201256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2020 |
| Decision Date | November 04, 2022 |
| Days to Decision | 907 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCK - C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |