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510(k) K181675

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System by Taidoc Technology Corporation — Product Code PTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2018
Date Received
June 25, 2018
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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