Luminex Molecular Diagnostics, Inc. · Class II · Cleared Sep 1, 2009
| K-number | K083846 |
| Device name | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
| Applicant | Luminex Molecular Diagnostics, Inc. |
| Product code | NUA |
| Device class | Class II |
| Decision date | Sep 1, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 866.5900 |
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