Clearance Summary
AUTOSTATTMII ANTI-DSDNA received FDA 510(k) clearance under submission number K952567, 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 1997-03-04.
- Submission: K952567
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1997-03-04
Classification & Regulation
This clearance is catalogued under FDA product code LRM and 21 CFR 866.5100, within the Immunology review panel as a Class II device.