510(k) K093420 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
| Applicant | Luminex Molecular Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Aug 26, 2010 |
| Received | Nov 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Luminex Corporation xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373
The xTAG CYP2D6 Kit v3 is a device Terminated |
NTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.