xTAG Cystic Fibrosis 39 Kit v2— 510(k) K163347
UnknownLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K163347 for xTAG Cystic Fibrosis 39 Kit v2, 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
view all- K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- K083845 — XTAG CF60 KIT V2
- K083846 — XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
- 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.