xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR— 510(k) K163336
UnknownLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K163336 for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR, Unknown on 2016-12-15. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Product code
- Code NUA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Toronto, CA
Recent devices under product code NUA
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- K083294 — VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
- K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
More clearances from Luminex Molecular Diagnostics, Inc.
view all- K242613 — NxTAG® Respiratory Pathogen Panel
- K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K191161 — xTAG Gastrointestinal Pathogen Panel (GPP)
- K191160 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Data sourced from openFDA. This site is unofficial and independent of the FDA.