Clearance Summary
1-125 LABELED TRIIODOTHYRONINE(T3) received FDA 510(k) clearance under submission number K803180, 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 1981-01-09.
- Submission: K803180
- Applicant / Sponsor: Pcl-Ria, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1981-01-09
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.