510(k) K242209
K242209 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "UASure II Blood Uric Acid Monitoring System". The FDA issued a decision of Substantially Equivalent on April 4, 2025. 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. Apex BioTechnology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2025
- Date Received
- July 29, 2024
- 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.