Clearance Summary
TSH-SQUIBB RADIOIMMUNOASSAY KIT received FDA 510(k) clearance under submission number K821174, sponsored by Squibb & Sons, 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 1982-05-14.
- Submission: K821174
- Applicant / Sponsor: Squibb & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1982-05-14
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.