Clearance Summary
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA received FDA 510(k) clearance under submission number K043433, sponsored by Hycor Biomedical , 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 2005-03-07.
- Submission: K043433
- Applicant / Sponsor: Hycor Biomedical , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2005-03-07
Classification & Regulation
This clearance is catalogued under FDA product code MVM and 21 CFR 866.5660, within the Immunology review panel as a Class II device.