510(k) K052867 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 23, 2005 |
| Received | Oct 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD) Terminated |
JMO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.