Clearance Summary
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance under submission number K884180, 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 1989-02-03.
- Submission: K884180
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1989-02-03
Classification & Regulation
This clearance is catalogued under FDA product code DHR and 21 CFR 866.5775, within the Immunology review panel as a Class II device.