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FDA Product Code

FDA Product Code PTC — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1775

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K242209 UASure II Blood Uric Acid Monitoring System Apex BioTechnology Corp. 2025-04-04 Traditional PDF ↗
K181675 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System Taidoc Technology Corporation 2018-12-10 Traditional PDF ↗
K160990 Nova Max Uric Acid Monitoring System Nova Biomedical Corporation 2017-04-11 Traditional PDF ↗

Product code PTC · Class I · Clinical Chemistry. Data: openFDA.