510(k) K002585 ยท DDG Transferrin, Antigen, Antiserum, Control
RANDOX TRANSFERRIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Feb 5, 2001 |
| Received | Aug 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2022 | Randox Laboratories Ltd. Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD Terminated |
DDG | None listed |
| Jun 9, 2022 | Randox Laboratories Ltd. Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD Terminated |
DDG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.