Clearance Summary
FIAX TEST FOR ANTI-RUBELLA ANTIBODY received FDA 510(k) clearance under submission number K772219, sponsored by Idt, A Division of Whittaker M.A. Bioproducts. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1978-01-20.
- Submission: K772219
- Applicant / Sponsor: Idt, A Division of Whittaker M.A. Bioproducts
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1978-01-20
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.