510(k) K121603 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121603
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.