UASure II Blood Uric Acid Monitoring System— 510(k) K242209

Substantially Equivalent

Apex 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..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code PTC
Advisory panel: Clinical Chemistry
Date received: 2024-07-29
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

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