Clearance Summary
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA received FDA 510(k) clearance under submission number K991942, 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 1999-08-24.
- Submission: K991942
- Applicant / Sponsor: Cogent Diagnotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5110
- Decision date: 1999-08-24
Classification & Regulation
This clearance is catalogued under FDA product code MLE and 21 CFR 866.5110, within the Immunology review panel as a Class II device.