510(k) K121746 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jul 11, 2012 |
| Received | Jun 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121746
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.