510(k) K130189 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, May 21, 2013 |
| Received | Jan 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130189
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.