510(k) K011853 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 17, 2001 |
| Received | Jun 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011853
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.