510(k) K002905 ยท MSW System, Test, Thyroglobulin
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
| Applicant | Beckman Coulter, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 19, 2000 |
| Received | Sep 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniCel DxI Terminated |
MSW | None listed |
| May 9, 2017 | Beckman Coulter Inc. Access Thyroglobulin, A34085G, Catalog No. 33860 Terminated |
MSW | None listed |
| Sep 3, 2015 | Beckman Coulter Inc. Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. Terminated |
MSW | None listed |
| May 19, 2011 | Beckman Coulter Inc. Access Immunoassay Systems Thyroglobulin,
Part Number: 33860
This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid glan Terminated |
MSW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.