Clearance Summary
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) received FDA 510(k) clearance under submission number K183313, sponsored by Euroimmun Us, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-02-28.
- Submission: K183313
- Applicant / Sponsor: Euroimmun Us, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2019-02-28
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.