510(k) K000318 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Feb 28, 2000 |
| Received | Feb 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000318
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.