Clearance Summary
THYROXINE (T4) 125I received FDA 510(k) clearance under submission number K812666, sponsored by Pcl-Ria, Inc.. 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 1981-10-02.
- Submission: K812666
- Applicant / Sponsor: Pcl-Ria, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1981-10-02
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.