Clearance Summary
IBL CORTISOL LIA TEST KIT received FDA 510(k) clearance under submission number K052359, sponsored by Lehnus & Associates Consulting. 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 2005-10-03.
- Submission: K052359
- Applicant / Sponsor: Lehnus & Associates Consulting
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 2005-10-03
Classification & Regulation
This clearance is catalogued under FDA product code CGR and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.