K231974 is an FDA 510(k) clearance for the PATHFAST®hs-cTnI-II. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Phc Corporation (Tokyo, JP). The FDA issued a Cleared decision on March 20, 2024, 261 days after receiving the submission on July 3, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K231974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | March 20, 2024 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MMI - Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |