Clearance Summary
xTAG Cystic Fibrosis 39 Kit v2 received FDA 510(k) clearance under submission number K163347, sponsored by Luminex Molecular Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-12-15.
- Submission: K163347
- Applicant / Sponsor: Luminex Molecular Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5900
- Decision date: 2016-12-15
Classification & Regulation
This clearance is catalogued under FDA product code NUA and 21 CFR 866.5900, within the Immunology review panel as a Class II device.