510(k) K011579 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 26, 2001 |
| Received | May 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011579
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.