510(k) K123966 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
GLUCOSE METER-CHECK SOLUTION FOR BAYER
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Jan 25, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123966
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.