510(k) K121588 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jun 20, 2012 |
| Received | May 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121588
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.