Clearance Summary
INFINITT DPS received FDA 510(k) clearance under submission number K243449, sponsored by Infinitt Healthcare Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2025-12-09.
- Submission: K243449
- Applicant / Sponsor: Infinitt Healthcare Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2025-12-09
Classification & Regulation
This clearance is catalogued under FDA product code QKQ and 21 CFR 864.3700, within the Pathology review panel as a Class II device.