Panels › Clinical Chemistry › Product code SHB · Class 2
Creatinine Test System For At Home Prescription Use
Regulation 862.1225
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SHB
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 21, 2026 | K251281 | Nova Max Creat eGFR Monitoring System Nova Biomedical Corporation | SHB |
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