Clearance Summary
RADIOIMMUNOASSAY TEST SYSTEM received FDA 510(k) clearance under submission number K791096, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1979-08-03.
- Submission: K791096
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1979-08-03
Classification & Regulation
This clearance is catalogued under FDA product code JMG and 21 CFR 866.5340, within the Immunology review panel as a Class II device.