Cleared Traditional

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System

K181675 · Taidoc Technology Corporation · Chemistry
Dec 2018
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K181675 is an FDA 510(k) clearance for the FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System, a Uric Acid Test System For At Home Prescription Use (Class I — General Controls, product code PTC), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 10, 2018, 168 days after receiving the submission on June 25, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K181675 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2018
Decision Date December 10, 2018
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code PTC — Uric Acid Test System For At Home Prescription Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775
Definition For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.