510(k) K082395 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Sep 18, 2008 |
| Received | Aug 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082395
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.