Clearance Summary
CORNING'S MAGIC T3(125I) RADIOIMMUNO- received FDA 510(k) clearance under submission number K832353, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1983-08-31.
- Submission: K832353
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1983-08-31
Classification & Regulation
This clearance is catalogued under FDA product code CDP and 21 CFR 862.1710, within the Clinical Chemistry review panel as a Class II device.