510(k) K140522 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, May 22, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.
Catalog Number: IA2640 Open, Classified |
JJY | None listed |
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
Catalog Number: IA2633 Open, Classified |
JJY | None listed |
| Feb 7, 2019 | Randox Laboratories Ltd. Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and Terminated |
JJY | None listed |
| Aug 11, 2017 | Randox Laboratories Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) Terminated |
JJY | None listed |
| Aug 11, 2017 | Randox Laboratories Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.