Clearance Summary
PHASE II T3 RADIOIMMUNOASSAY KIT received FDA 510(k) clearance under submission number K831064, sponsored by Medical & Scientific Designs, 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 1983-05-09.
- Submission: K831064
- Applicant / Sponsor: Medical & Scientific Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1983-05-09
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.