510(k) K160990
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2017
- Date Received
- April 8, 2016
- 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.