K212559 is an FDA 510(k) clearance for the CardioPhase® hsCRP. This device is classified as a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code NQD).
Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on December 16, 2022, 490 days after receiving the submission on August 13, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270. In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments..
| 510(k) Number | K212559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2021 |
| Decision Date | December 16, 2022 |
| Days to Decision | 490 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NQD — Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |
| Definition | In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments. |