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

FDA 510(k) K181675 · Taidoc Technology Corporation

Substantially Equivalent

510(k) numberK181675

Submission

Device name
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
Applicant
Taidoc Technology Corporation
New Taipei City, TW
Received
June 25, 2018
Decision date
December 10, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PTC – Uric Acid Test System For At Home Prescription Use
Device class
Class I (low risk)
Regulation
21 CFR 862.1775
Specialty
Clinical Chemistry

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

Other 510(k)s with product code PTC

510(k)DeviceApplicantDecision
K242209UASure II Blood Uric Acid Monitoring SystemPTC · Traditional Apex BioTechnology Corp.04/04/2025SE
K160990Nova Max Uric Acid Monitoring SystemPTC · Traditional Nova Biomedical Corporation04/11/2017SE

More from Nova Biomedical Corporation

510(k)DeviceDecision
K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track 11/19/2024SE
K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional 06/16/2022SE
K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional 04/05/2022SE
K190579TD-4183 Blood Glucose Monitoring SystemNBW · Traditional 06/04/2019SE
K182934FORA P100 Blood Pressure Monitoring SystemDXN · Traditional 02/12/2019SE
K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional 12/19/2018SE
K181588POPS! one Blood Glucose Monitoring SystemNBW · Traditional 11/30/2018SE
K172733TD-1035 ThermometerFLL · Traditional 10/22/2018SE
K173511ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special 07/12/2018SE
K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100MWI · Traditional 06/06/2018SE

Questions and answers

When was FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System cleared by the FDA?

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (K181675) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 168 days after the submission was received.

What is the product code of K181675?

The FDA product code is PTC – Uric Acid Test System For At Home Prescription Use, a Class I (low risk) device regulated under 21 CFR 862.1775.