Clearance Summary
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS received FDA 510(k) clearance under submission number K020349, sponsored by Axis-Shield Diagnostics, 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 2002-05-02.
- Submission: K020349
- Applicant / Sponsor: Axis-Shield Diagnostics, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5870
- Decision date: 2002-05-02
Classification & Regulation
This clearance is catalogued under FDA product code JZO and 21 CFR 866.5870, within the Immunology review panel as a Class II device.