Clearance Summary
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device received FDA 510(k) clearance under submission number K133303, sponsored by 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 2014-11-19.
- Submission: K133303
- Applicant / Sponsor: Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2014-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.