Clearance Summary
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA received FDA 510(k) clearance under submission number K993085, 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 2000-02-01.
- Submission: K993085
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2000-02-01
Classification & Regulation
This clearance is catalogued under FDA product code MID and 21 CFR 866.5660, within the Immunology review panel as a Class II device.