← DeviceClear
HomeDevice Clearances

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR — Luminex Molecular Diagnostics, Inc. (510(k) K163336)

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR — Luminex Molecular Diagnostics, Inc. (510(k) K163336) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR; Applicant: Luminex Molecular Di

Device namexTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
ApplicantLuminex Molecular Diagnostics, Inc.
Clearance track510(k)
Submission numberK163336
DecisionUnknown
Decision date2016-12-15
Date received2016-11-28
Product codeNUA
Device class2
Medical specialtyImmunology
Applicant locationCA
SourceopenFDA device

🔍 Search all device clearances →