510(k) K131554 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jan 9, 2014 |
| Received | May 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Randox Laboratories Ltd. RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser
(1) RX4041, (2) RX4041R (refurbished) Open, Classified |
CIT | None listed |
| Feb 24, 2020 | Randox Laboratories, Limited RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage:
A fully automated, random access, clinical chemistry analyzer complete with dedicated analy Terminated |
JJE | None listed |
| Jun 24, 2019 | Randox Laboratories, Limited RX Daytona, Model Nos. RX4040 and RX4041 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.