510(k) K140971 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Dec 8, 2014 |
| Received | Apr 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140971
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2023 | Randox Laboratories Ltd. Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 Open, Classified |
JJY | None listed |
| Feb 18, 2020 | Randox Laboratories Ltd. Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for t Open, Classified |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.