510(k) K042815 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
QUEST TUMOR MARKER CONTROL, MODEL 955
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 5, 2004 |
| Received | Oct 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042815
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.