510(k) K061190 ยท CEW Radioimmunoassay, Parathyroid Hormone
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 15, 2006 |
| Received | Apr 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2025 | Beckman Coulter, Inc. Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using Open, Classified |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.