PTC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Uric Acid Test System For At Home Prescription Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA definition
- For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
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| Record | Firm | Date |
|---|---|---|
| UASure II Blood Uric Acid Monitoring System (K242209) | Apex BioTechnology Corp. | 2025-04-04 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.