The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cystic Fibrosis 39 Kit V2, (cftr 39 Kit V2), Model I027c0231, I027d0266, I027e0267.
| Device ID | K083846 |
| 510k Number | K083846 |
| Device Name: | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Contact | Gloria Lee |
| Correspondent | Gloria Lee LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-09-01 |
| Summary: | summary |