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510(k) K242209

Device
UASure II Blood Uric Acid Monitoring System
Applicant
Apex BioTechnology Corp.
510(k) number
K242209
Product code
PTC
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-04
Date received
2024-07-29
Regulation
862.1775
Classification name
Uric Acid Test System For At Home Prescription Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Lisa Liu
Address
#7, Li-Hsin Rd. V, Hsinchu Science Park Hsinchu TW 30078 30078

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PTC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181675FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemTaidoc Technology Corporation2018-12-10
K160990Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation2017-04-11