Panels › Clinical Chemistry › Product code PTC · Class 1
Uric Acid Test System For At Home Prescription Use
Regulation 862.1775
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in PTC
| Company | 510(k)s | Recalls |
|---|---|---|
| Visgeneer, Inc. | 0 | 2 |
| Apex BioTechnology Corp. | 1 | 0 |
| Nova Biomedical Corporation | 1 | 0 |
| Taidoc Technology Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2025 | K242209 | UASure II Blood Uric Acid Monitoring System Apex BioTechnology Corp., TW | PTC |
| Dec 10, 2018 | K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System Taidoc Technology Corporation, TW | PTC |
| Apr 11, 2017 | K160990 | Nova Max Uric Acid Monitoring System Nova Biomedical Corporation | PTC |
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