510(k) K110436 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
| Applicant | Fujirebio Diagnostics,Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Apr 20, 2011 |
| Received | Feb 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110436
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.