Clearance Summary
AUTOSTAT ANTI-DSDNA received FDA 510(k) clearance under submission number K925783, sponsored by Cogent Diagnotics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1993-03-22.
- Submission: K925783
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1993-03-22
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.