The following data is part of a premarket notification filed by Procise Diagnostics with the FDA for Procise Crp, Procisedx Analyzer, Procisedx Calibration Cartridge.
| Device ID | K201256 |
| 510k Number | K201256 |
| Device Name: | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | Procise Diagnostics 9449 Carroll Park Drive San Diego, CA 92121 |
| Contact | Dan Kiser |
| Correspondent | Kurtis Bray Procise Diagnostics 9449 Carroll Park Drive San Diego, CA 92121 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2022-11-04 |