The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cf60 Kit V2.
| Device ID | K083845 |
| 510k Number | K083845 |
| Device Name: | XTAG CF60 KIT V2 |
| 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 | 2009-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100479 | K083845 | 000 |