510(k) K131776 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jul 18, 2013 |
| Received | Jun 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131776
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.