Clearance Summary
IMMULITE® 2000 Cortisol received FDA 510(k) clearance under submission number K202826, sponsored by Siemens Healthcare Diagnostics Products, 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 2021-01-15.
- Submission: K202826
- Applicant / Sponsor: Siemens Healthcare Diagnostics Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 2021-01-15
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.