510(k) K032819 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Oct 20, 2003 |
| Received | Sep 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032819
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.