K181675 is an FDA 510(k) clearance for the FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1775. For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only..
| 510(k) Number | K181675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |