510(k) K092645 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
| Applicant | Fujirebio Diagnostics,Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Sep 5, 2009 |
| Received | Aug 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092645
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.