Clearance Summary
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT received FDA 510(k) clearance under submission number K982634, sponsored by Oxoid , 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 1999-01-28.
- Submission: K982634
- Applicant / Sponsor: Oxoid , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5640
- Decision date: 1999-01-28
Classification & Regulation
This clearance is catalogued under FDA product code KTN and 21 CFR 866.5640, within the Immunology review panel as a Class II device.