510(k) K163015 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
| Applicant | Bio-Rad Laboratories, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 10, 2017 |
| Received | Oct 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163015
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.