Clearance Summary
Cortisol Saliva Luminescence Immunoassay received FDA 510(k) clearance under submission number K150528, sponsored by Ibl International GmbH. 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 2015-11-25.
- Submission: K150528
- Applicant / Sponsor: Ibl International GmbH
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 2015-11-25
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.