510(k) K190298 ยท CDD Radioassay, Vitamin B12
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
| Applicant | Beckman Coulter Biomedical GmbH, Munich, DE |
| Decision | Substantially Equivalent, Oct 4, 2019 |
| Received | Feb 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | None listed |
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | None listed |
| Jul 21, 2021 | Beckman Coulter Inc. DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118 Terminated |
JJE | None listed |
| Jun 17, 2020 | Beckman Coulter Biomedical GmbH DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample pro Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.