Cleared Dual Track

StatStrip Glucose Hospital Meter System

K181043 · Nova Biomedical Corporation · Chemistry

Jul 2018

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K181043 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 July 12, 2018, 84 days after receiving the submission on April 19, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K181043 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2018
Decision Date	July 12, 2018
Days to Decision	84 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.