510(k) K860418 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
CREATININE REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Feb 11, 1986 |
| Received | Feb 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.