Clearance Summary
IDS Cortisol received FDA 510(k) clearance under submission number K202136, sponsored by Immunodiagnostic Systems , Ltd.. 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 2021-04-13.
- Submission: K202136
- Applicant / Sponsor: Immunodiagnostic Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 2021-04-13
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.