510(k) K051114 ยท JIF Enzymatic Method, Ammonia
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
| Applicant | Sentinel Ch. Srl, Milano, IT |
| Decision | Substantially Equivalent, Nov 25, 2005 |
| Received | May 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2015 | Sentinel CH SpA Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.