Clearance Summary
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K102841, 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 2012-05-08.
- Submission: K102841
- Applicant / Sponsor: Pantex, Div. Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 2012-05-08
Classification & Regulation
This clearance is catalogued under FDA product code NHG and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.