510(k) K231974 · MMI Immunoassay Method, Troponin Subunit
PATHFAST®hs-cTnI-II
| Applicant | Phc Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Mar 20, 2024 |
| Received | Jul 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231974
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.