Clearance Summary
MAGIC TM 125I T3 UPTAKE RADIOASSAY received FDA 510(k) clearance under submission number K831613, 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 1983-08-11.
- Submission: K831613
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1715
- Decision date: 1983-08-11
Classification & Regulation
This clearance is catalogued under FDA product code KHQ and 21 CFR 862.1715, within the Clinical Chemistry review panel as a Class II device.