The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cystic Fibrosis 60 Kit V2, Xtag Data Analysis Software (tdas) Cftr.
| Device ID | K163336 |
| 510k Number | K163336 |
| Device Name: | XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| 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 | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2016-12-15 |