510(k) K854335 ยท CGA Glucose Oxidase, Glucose
GLUCOSE REAGENT SET (GOD/TRINDER)
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Nov 22, 1985 |
| Received | Oct 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.