Clearance Summary
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER received FDA 510(k) clearance under submission number K122062, sponsored by Gen-Probe, 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 2013-01-09.
- Submission: K122062
- Applicant / Sponsor: Gen-Probe, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.3860
- Decision date: 2013-01-09
Classification & Regulation
This clearance is catalogued under FDA product code OUY and 21 CFR 866.3860, within the Immunology review panel as a Class II device.