510(k) K163336
- Device
- XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR
- Applicant
- Luminex Molecular Diagnostics, Inc.
- 510(k) number
- K163336
- Product code
- NUA
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2016-12-15
- Date received
- 2016-11-28
- Regulation
- 866.5900
- Classification name
- System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Medical specialty
- Immunology
- Review panel
- Molecular Genetics
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Grimes
- Address
- 439 University Ave. Toronto CA M5G 1Y8 M5G 1Y8
FDA Registration Numbers#
- 3002777243
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NUA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | 2016-12-15 |
| K083845 | XTAG CF60 KIT V2 | Luminex Molecular Diagnostics, Inc. | 2009-12-11 |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | Luminex Molecular Diagnostics, Inc. | 2009-09-01 |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | Nanosphere, Inc. | 2009-07-24 |
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 | Osmetech Molecular Diagnostics | 2009-07-06 |
| K063787 | INPLEX CF MOLECULAR TEST | Third Wave Technologies, Inc. | 2008-03-13 |
| K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | Celera Diagnostics | 2007-09-07 |
| K060627 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | 2006-06-07 |
| K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | Clinical Micro Sensors, Inc. | 2006-03-28 |
| K051435 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 | Clinical Micro Sensors | 2006-01-19 |
| DEN050004 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | 2005-05-09 |
Legacy Summary#
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FDA Review#
Decision Summary