Clearance Summary
QAB2A IGM ELISA KIT received FDA 510(k) clearance under submission number K020694, sponsored by Cheshire 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 2002-04-19.
- Submission: K020694
- Applicant / Sponsor: Cheshire Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2002-04-19
Classification & Regulation
This clearance is catalogued under FDA product code MVS and 21 CFR 866.5660, within the Immunology review panel as a Class II device.