510(k) K181675
K181675 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System". The FDA issued a decision of Substantially Equivalent on December 10, 2018. The device falls under product code PTC (Uric Acid Test System For At Home Prescription Use), a Class I device regulated under 21 CFR 862.1775. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.
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.