510(k) K140496 ยท CDD Radioassay, Vitamin B12
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Sep 16, 2014 |
| Received | Feb 27, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH Power Express, REF B90918 Open, Classified |
CDD | None listed |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge, REF: B36365, a component of the Power Express Open, Classified |
CDD | None listed |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express. Open, Classified |
CDD | None listed |
| May 17, 2019 | Beckman Coulter Inc. Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.