Clearance Summary
AUTOSTAT II ENA SCREEN ELISA received FDA 510(k) clearance under submission number K983921, 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 1998-12-28.
- Submission: K983921
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1998-12-28
Classification & Regulation
This clearance is catalogued under FDA product code LLL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.