510(k) K040379 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX IMMUNOASSAY CONTROL
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jun 16, 2004 |
| Received | Feb 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2019 | Randox Laboratories Ltd. Immunoassay Premium Controls, Model Numbers IA2633 and IA2638
Product Usage:
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and repr Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.