Clearance Summary
QUIDEL CH50 EQ EIA received FDA 510(k) clearance under submission number K974111, sponsored by Quidel Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-07-29.
- Submission: K974111
- Applicant / Sponsor: Quidel Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 1998-07-29
Classification & Regulation
This clearance is catalogued under FDA product code DAE and 21 CFR 866.5240, within the Immunology review panel as a Class II device.