Clearance Summary
INPLEX CF MOLECULAR TEST received FDA 510(k) clearance under submission number K063787, sponsored by Third Wave Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-03-13.
- Submission: K063787
- Applicant / Sponsor: Third Wave Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5900
- Decision date: 2008-03-13
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.