510(k) K103450 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
| Applicant | Fujirebio Diagnostics,Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Jan 25, 2011 |
| Received | Nov 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103450
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.