510(k) K131565 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
XTAG CYP2C19 KIT V3
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Sep 11, 2013 |
| Received | May 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131565
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.