510(k) K860478 ยท JIY Photometric Method, Iron (Non-Heme)
SERUM IRON & IRON BINDING REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Mar 14, 1986 |
| Received | Feb 7, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed Terminated |
JIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.