Clearance Summary
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA received FDA 510(k) clearance under submission number K213510, sponsored by Siemens Healthcare Diagnostics Products, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2023-09-08.
- Submission: K213510
- Applicant / Sponsor: Siemens Healthcare Diagnostics Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2023-09-08
Classification & Regulation
This clearance is catalogued under FDA product code LTK and 21 CFR 866.6010, within the Immunology review panel as a Class II device.