StatStrip Glucose Hospital Meter System— 510(k) K232075
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K232075 for StatStrip Glucose Hospital Meter System, Substantially Equivalent on 2024-02-23. Applicant: Nova Biomedical Corporation. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code PZI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Walham, MA, US
Recent devices under product code PZI
view allMore clearances from Nova Biomedical Corporation
view allRecalls naming K232075
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232075.
Data sourced from openFDA. This site is unofficial and independent of the FDA.