Cleared Traditional

StatStrip Xpress Blood Glucose Monitoring System

K170464 · Nova Biomedical Corporation · Chemistry
Nov 2017
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K170464 is an FDA 510(k) clearance for the StatStrip Xpress Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on November 7, 2017, 265 days after receiving the submission on February 15, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K170464 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2017
Decision Date November 07, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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