510(k) K052914 ยท CEM Electrode, Ion Specific, Potassium
RX IMOLA
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Mar 31, 2006 |
| Received | Oct 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Randox Laboratories Ltd. RX Imola-IVD Clinical Chemistry Analyzer
Catalog Number: RX4900. RX4900R (refurbished) Open, Classified |
CEM | None listed |
| Jun 24, 2019 | Randox Laboratories, Limited RX Imola, Model Nos. RX4900 Terminated |
JJE | None listed |
| May 4, 2018 | Randox Laboratories RX Imola (RX4900)
For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. Terminated |
JJE | None listed |
| Apr 14, 2016 | Randox Laboratories, Limited Magnesium on RX Imola analyser
IVD Terminated |
JGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.