510(k) K050536 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 24, 2005 |
| Received | Mar 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050536
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.