510(k) K131999 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jul 26, 2013 |
| Received | Jun 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131999
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.