Cleared Dual Track

StatStrip Glucose Hospital Meter System

K232075 · Nova Biomedical Corporation · Chemistry

Feb 2024

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K232075 is an FDA 510(k) clearance for the StatStrip Glucose Hospital Meter System, a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II — Special Controls, product code PZI), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on February 23, 2024, 226 days after receiving the submission on July 12, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K232075 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2023
Decision Date	February 23, 2024
Days to Decision	226 days
Submission Type	Dual Track
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PZI — Prescription Use Blood Glucose Meter For Near-patient Testing
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1345
Definition	Intended For Use In Near-patient Testing Settings For In Vitro Diagnostic, Multiple-patient Use For The Quantitative Determination Of Glucose Throughout All Hospital And All Professional Healthcare Settings For Use In Determining Dysglycemia.