510(k) K123677 ยท JIF Enzymatic Method, Ammonia
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Mar 7, 2013 |
| Received | Nov 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.