510(k) K091914 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091914
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.