Clearance Summary
Atellica IM Total PSA II (tPSAII) received FDA 510(k) clearance under submission number K251630, sponsored by Siemens Healthcare Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2026-01-05.
- Submission: K251630
- Applicant / Sponsor: Siemens Healthcare Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2026-01-05
Classification & Regulation
This clearance is catalogued under FDA product code LTJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.