UASure II Blood Uric Acid Monitoring System— 510(k) K242209
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K242209 for UASure II Blood Uric Acid Monitoring System, Substantially Equivalent on 2025-04-04. Applicant: Apex BioTechnology Corp.. Device class: 1.
Clearance details
- Applicant
- Apex BioTechnology Corp.
- Product code
- Code PTC
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.