Clearance Summary
AUTOSTAT II ANTI-THYROGLOBULIN received FDA 510(k) clearance under submission number K943625, sponsored by Cogent Diagnotics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1994-12-22.
- Submission: K943625
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 1994-12-22
Classification & Regulation
This clearance is catalogued under FDA product code DDC and 21 CFR 866.5870, within the Immunology review panel as a Class II device.