510(k) K232791 ยท CEW Radioimmunoassay, Parathyroid Hormone
Access Intact PTH
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 1, 2024 |
| Received | Sep 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2024 | Beckman Coulter Inc. Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and Open, Classified |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.