K242209
- 510(k) number
- K242209
- Device name
- UASure II Blood Uric Acid Monitoring System
- Applicant
- Apex BioTechnology Corp. TW
- Product code
- PTC — Uric Acid Test System For At Home Prescription Use
- Decision date
- 2025-04-04
- Date received
- 2024-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242209.pdf
Official FDA record: K242209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.