510(k) K130337 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Jun 19, 2013 |
| Received | Feb 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130337
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.