Clearance Summary
IDS ACTH II received FDA 510(k) clearance under submission number K223867, sponsored by Immunodiagnostic Systems Limited. 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 2023-08-18.
- Submission: K223867
- Applicant / Sponsor: Immunodiagnostic Systems Limited
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1025
- Decision date: 2023-08-18
Classification & Regulation
This clearance is catalogued under FDA product code CKG and 21 CFR 862.1025, within the Clinical Chemistry review panel as a Class II device.