510(k) K110904 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Mar 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2023 | Randox Laboratories Ltd. Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Open, Classified |
JJY | None listed |
| May 26, 2017 | Randox Laboratories Liquid Urine Control Level 3
For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.