510(k) K232075 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
StatStrip Glucose Hospital Meter System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Feb 23, 2024 |
| Received | Jul 12, 2023 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K232075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 63685. 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.