510(k) K041793 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Jul 16, 2004 |
| Received | Jul 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2025 | Beckman Coulter Inc. UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, Open, Classified |
JMO | None listed |
| Aug 18, 2020 | Beckman Coulter Inc. UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding C Terminated |
JMO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.