The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cyp2d6 Kit V3.
| Device ID | K170492 |
| 510k Number | K170492 |
| Device Name: | XTAG CYP2D6 Kit V3 |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, CA M5g 1y8 |
| Contact | Jennifer Grimes |
| Correspondent | Jennifer Grimes Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, CA M5g 1y8 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-08-11 |