510(k) K150879 ยท CEW Radioimmunoassay, Parathyroid Hormone
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jun 22, 2015 |
| Received | Apr 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2020 | Diasorin Inc. LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Mea Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.