FDA Product Code
FDA Product Code NUA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5900
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | 2016-12-15 | Special | PDF ↗ |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Luminex Molecular Diagnostics, Inc. | 2016-12-15 | Special | PDF ↗ |
| K083845 | XTAG CF60 KIT V2 | Luminex Molecular Diagnostics, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | Luminex Molecular Diagnostics, Inc. | 2009-09-01 | Traditional | PDF ↗ |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | Nanosphere, Inc. | 2009-07-24 | Traditional | PDF ↗ |
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 | Osmetech Molecular Diagnostics | 2009-07-06 | Traditional | PDF ↗ |
| K063787 | INPLEX CF MOLECULAR TEST | Third Wave Technologies, Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | Celera Diagnostics | 2007-09-07 | Traditional | PDF ↗ |
| K060627 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | 2006-06-07 | Special | PDF ↗ |
| K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | Clinical Micro Sensors, Inc. | 2006-03-28 | Special | PDF ↗ |
| K051435 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 | Clinical Micro Sensors | 2006-01-19 | Traditional | PDF ↗ |
| DEN050004 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | 2005-05-09 | Post-NSE | — |
Product code NUA · Class II · Immunology. Data: openFDA.