Clearance Summary
RIA FOR SERUM THYROXINE received FDA 510(k) clearance under submission number K771415, 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 1978-01-05.
- Submission: K771415
- Applicant / Sponsor: Clinical Immuno-Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1978-01-05
Classification & Regulation
This clearance is catalogued under FDA product code CDX and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.