Clearance Summary
UASure II Blood Uric Acid Monitoring System received FDA 510(k) clearance under submission number K242209, sponsored by Apex BioTechnology Corp.. 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 2025-04-04.
- Submission: K242209
- Applicant / Sponsor: Apex BioTechnology Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1775
- Decision date: 2025-04-04
Classification & Regulation
This clearance is catalogued under FDA product code PTC and 21 CFR 862.1775, within the Clinical Chemistry review panel as a Class I device.