510(k) K101921 ยท CEW Radioimmunoassay, Parathyroid Hormone
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 22, 2010 |
| Received | Jul 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101921
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin)
Catalog Number: 6802892 Open, Classified |
CEW | None listed |
| Oct 5, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators
For the quantitative Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.