Clearance Summary
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA received FDA 510(k) clearance under submission number K994338, 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 2000-02-03.
- Submission: K994338
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2000-02-03
Classification & Regulation
This clearance is catalogued under FDA product code DHR and 21 CFR 866.5775, within the Immunology review panel as a Class II device.