Clearance Summary
THYRO-INDICATOR T-3 125I received FDA 510(k) clearance under submission number K780018, sponsored by Clinical Immuno-Diagnostics. 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 1978-02-07.
- Submission: K780018
- Applicant / Sponsor: Clinical Immuno-Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1978-02-07
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.