UASure II Blood Uric Acid Monitoring System
FDA 510(k) clearance K242209 · decided 2025-04-04
Clearance details
- K-number
- K242209
- Device name
- UASure II Blood Uric Acid Monitoring System
- Applicant
- Apex BioTechnology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-29
- Decision date
- 2025-04-04
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- PTC
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (K181675) | Taidoc Technology Corporation | 2018-12-10 |
| Nova Max Uric Acid Monitoring System (K160990) | Nova Biomedical Corporation | 2017-04-11 |
Recalls involving this device
No recalls on record reference this clearance.