K232075
- 510(k) number
- K232075
- Device name
- StatStrip Glucose Hospital Meter System
- Applicant
- Nova Biomedical Corporation MA · US
- Product code
- PZI — Prescription Use Blood Glucose Meter For Near-Patien
- Decision date
- 2024-02-23
- Date received
- 2023-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232075.pdf
Official FDA record: K232075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.