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510(k) K242209

UASure II Blood Uric Acid Monitoring System by Apex BioTechnology Corp. — Product Code PTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
July 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uric Acid Test System For At Home Prescription Use
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.

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