Documento fuente o registro público
FDA 510(k) K232075 — StatStrip Glucose Hospital Meter System
FDA 510(k) index record K232075. Device: StatStrip Glucose Hospital Meter System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2024-02-23.
Fuente
"device_name": "StatStrip Glucose Hospital Meter System"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-27
professional use
FDA 510(k) public index record K232075.
Device name: StatStrip Glucose Hospital Meter System. Applicant as listed: Nova Biomedical Corporation.
Decision date: 2024-02-23. Decision wording: Substantially Equivalent.
Product code: PZI. Regulation: 21 CFR 862.1345. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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