510(k) K860142 ยท LFQ Acid, Uric, Acid Reduction Of Ferric Ion
URIC ACID REAGENT SET (COLORIMETRIC)
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Feb 11, 1986 |
| Received | Jan 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is Terminated |
LFQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.