Clearance Summary
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance under submission number K854324, 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 1985-12-05.
- Submission: K854324
- Applicant / Sponsor: Pantex, Div. Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1985-12-05
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.