Clearance Summary
OXOID INFECTIOUS MONONUCLEOSIS KIT received FDA 510(k) clearance under submission number K883540, sponsored by Unipath , 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 1988-10-19.
- Submission: K883540
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5640
- Decision date: 1988-10-19
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.