510(k) K031683 ยท JIX Calibrator, Multi-Analyte Mixture
TOX AMMONIA CALIBRATOR
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 6, 2003 |
| Received | May 30, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems
S Open, Classified |
JLX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.