FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
K Number: K083846
·
Decision Sep 1, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
11
Applicant Total
26
Review Days
251
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Basic Information
- Device Name
- XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
- K Number
- K083846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5900
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Date Received
- December 24, 2008
- Decision Date
- September 1, 2009
- Product Code
- NUA
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | FDA class 2 | Immunology |
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Other Clearances by Luminex Molecular Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Oct 2, 2024 | Substantially Equivalent |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Mar 11, 2024 | Substantially Equivalent |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Dec 11, 2019 | Substantially Equivalent |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Nov 12, 2019 | Substantially Equivalent |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 4, 2019 | Substantially Equivalent |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Nov 30, 2018 | Substantially Equivalent |
| K170492 | xTAG CYP2D6 Kit v3 | Aug 11, 2017 | Substantially Equivalent |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Dec 15, 2016 | Unknown |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Dec 15, 2016 | Unknown |