510(k) K112337 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Dec 1, 2011 |
| Received | Aug 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2019 | Randox Laboratories Ltd. Liquid Immunoassay Premium Controls, Model Number LIA3105
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproduc Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.