The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cyp2c19 Kit V3.
| Device ID | K131565 |
| 510k Number | K131565 |
| Device Name: | XTAG CYP2C19 KIT V3 |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Contact | Ronald Dunn |
| Correspondent | Ronald Dunn 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 | 2013-05-30 |
| Decision Date | 2013-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100172 | K131565 | 000 |