510(k) K024014 ยท CGA Glucose Oxidase, Glucose
RANDOX RX DAYTONA
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Dec 4, 2003 |
| Received | Dec 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Randox Laboratories Ltd. RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser
Catalog Number: RX4040 Open, Classified |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.