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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2025 | Visgeneer, Inc. Blood Uric Acid Monitoring System
Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) Open, Classified |
PTC | None listed |
| Sep 2, 2025 | Visgeneer, Inc. Blood Uric Acid Monitoring System
Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) Open, Classified |
PTC | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.