Clearance Summary
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance under submission number K862447, sponsored by Pantex, Div. Bio-Analysis, 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 1986-10-07.
- Submission: K862447
- Applicant / Sponsor: Pantex, Div. Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1715
- Decision date: 1986-10-07
Classification & Regulation
This clearance is catalogued under FDA product code KHQ and 21 CFR 862.1715, within the Clinical Chemistry review panel as a Class II device.