510(k) K103553 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Feb 10, 2011 |
| Received | Dec 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103553
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.