510(k) K121790 ยท MMI Immunoassay Method, Troponin Subunit
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 25, 2013 |
| Received | Jun 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121790
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2026 | Beckman Coulter, Inc. Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit Open, Classified |
JJE | None listed |
| Jan 6, 2026 | Beckman Coulter, Inc. Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit Open, Classified |
JJE | None listed |
| Nov 4, 2025 | Beckman Coulter, Inc. Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer Open, Classified |
JJE | None listed |
| Nov 4, 2025 | Beckman Coulter, Inc. Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer Open, Classified |
JJE | None listed |
| Sep 23, 2014 | Beckman Coulter Inc. UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human b Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.