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510(k) K181675

Device
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
Applicant
TaiDoc Technology Corporation
510(k) number
K181675
Product code
PTC  
Decision
Substantially Equivalent (SESE)
Decision date
2018-12-10
Date received
2018-06-25
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
No

Applicant Contact#

Contact
Yvette Chang
Address
B1-7f, #127, Wugong 2nd Rd. New Taipei City TW 24888 24888

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
K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp.2025-04-04
K160990Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation2017-04-11

Legacy Summary#

summary

FDA Review#

Decision Summary