Clearance Summary
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO received FDA 510(k) clearance under submission number K853865, 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 1985-10-15.
- Submission: K853865
- Applicant / Sponsor: Pantex, Div. Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 1985-10-15
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.