510(k) K042732 ยท MOI System, Test, Immunological, Antigen, Tumor
ARCHITECT CA 15-3 ASSAY
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 22, 2004 |
| Received | Oct 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042732
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.