The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cyp2d6 Kit V3 (including Tdas Cyp2d6 Software).
| Device ID | K130189 |
| 510k Number | K130189 |
| Device Name: | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Contact | Lubna Syed |
| Correspondent | Lubna Syed LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-05-21 |
| Summary: | summary |