Panels › Clinical Chemistry › Product code PZI · Class 2
Prescription Use Blood Glucose Meter For Near-Patient Testing
Regulation 862.1345
1510(k)s in 12 months (14 all time)
5recalls in 12 months (6 all time)
3recalls that name a 510(k)
Top companies in PZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Biomedical Corporation | 10 | 6 |
| Roche Diagnostics | 2 | 0 |
| Arkray, Inc. | 1 | 0 |
| Taidoc Technology Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. Open, Classified |
PZI | K232075 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. Open, Classified |
PZI | K232075 |
| Dec 20, 2024 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing. Open, Classified |
PZI | K232075 |
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