510(k) K170492 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
xTAG CYP2D6 Kit v3
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Aug 11, 2017 |
| Received | Feb 17, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170492
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.