510(k) K110846 ยท JJW Urinalysis Controls (Assayed And Unassayed)
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Mar 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2019 | Randox Laboratories Ltd. Randox Urinalysis Control Level 2 (IVD)
Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips. Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.