StatStrip Glucose Hospital Meter System
FDA 510(k) clearance K232075 · decided 2024-02-23
Clearance details
- K-number
- K232075
- Device name
- StatStrip Glucose Hospital Meter System
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-07-12
- Decision date
- 2024-02-23
- Days to decision
- 226 days
- Clearance type
- Dual Track
- Product code
- PZI
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blo recall (Z-0681-2025) | Nova Biomedical Corporation | 2024-12-20 |