510(k) K172787 ยท MMI Immunoassay Method, Troponin Subunit
Access hsTnl
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Sep 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172787
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2021 | Beckman Coulter Inc. Access hsTnI High Sensitivity Troponin I, REF B52699
Access Immunoassay System REAGENT PACK Open, Classified |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.