510(k) K101809 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 5, 2010 |
| Received | Jun 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101809
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.