510(k) K860154 ยท CDL Berthelot Indophenol, Urea Nitrogen
BUN (ENZYMATIC BERTHELOT) REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Feb 6, 1986 |
| Received | Jan 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Sterling Diagnostics, Inc. Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. Terminated |
CDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.