Clearance Summary
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS received FDA 510(k) clearance under submission number K851891, sponsored by Richard Scott Elliott. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1985-07-19.
- Submission: K851891
- Applicant / Sponsor: Richard Scott Elliott
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1985-07-19
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.