Clearance Summary
AUTOSTAT II ENA-4 PROFILE ELISA received FDA 510(k) clearance under submission number K003057, 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 2000-10-13.
- Submission: K003057
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2000-10-13
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.