510(k) K230648 ยท MMI Immunoassay Method, Troponin Subunit
Access hsTnI
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 4, 2023 |
| Received | Mar 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Beckman Coulter, Inc. Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.
For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma. Open, Classified |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.