510(k) K023841 ยท JIF Enzymatic Method, Ammonia
AMMONIA ASSAY FOR THE ADVIA 1650
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 24, 2002 |
| Received | Nov 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023841
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratori Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.