Panels › Immunology › Product code NUA · Class 2
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Regulation 866.5900
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NUA
| Company | 510(k)s | Recalls |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 4 | 0 |
| Clinical Micro Sensors | 2 | 0 |
| Hologic, Inc | 0 | 2 |
| Tm Bioscience Corporation | 2 | 0 |
| Celera Diagnostics | 1 | 0 |
| Nanosphere, Inc. | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Third Wave Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2016 | K163347 | xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Dec 15, 2016 | K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc., CA | NUA |
| Dec 11, 2009 | K083845 | XTAG CF60 KIT V2 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Sep 1, 2009 | K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 Luminex Molecular Diagnostics, Inc., CA | NUA |
| Jul 24, 2009 | K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST Nanosphere, Inc. | NUA |
| Jul 6, 2009 | K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 Osmetech Molecular Diagnostics | NUA |
| Mar 13, 2008 | K063787 | INPLEX CF MOLECULAR TEST Third Wave Technologies, Inc. | NUA |
| Sep 7, 2007 | K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 Celera Diagnostics | NUA |
| Jun 7, 2006 | K060627 | TAG-IT CYSTIC FIBROSIS KIT Tm Bioscience Corporation, CA | NUA |
| Mar 28, 2006 | K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 Clinical Micro Sensors, Inc. | NUA |
| Jan 19, 2006 | K051435 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 Clinical Micro Sensors | NUA |
| May 9, 2005 | DEN050004 | TAG-IT CYSTIC FIBROSIS KIT Tm Bioscience Corporation, CA | NUA |
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