510(k) K002540 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Sep 18, 2000 |
| Received | Aug 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002540
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.