Clearance Summary
RA-80 POSITIVE CONTROL received FDA 510(k) clearance under submission number K813309, sponsored by Sun-Kit. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-12-17.
- Submission: K813309
- Applicant / Sponsor: Sun-Kit
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1981-12-17
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.