Cleared Special

EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM

K110435 · U. S. Diagnostics, Inc. · Chemistry
Sep 2011
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K110435 is an FDA 510(k) clearance for the EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by U. S. Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on September 21, 2011, 218 days after receiving the submission on February 15, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K110435 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2011
Decision Date September 21, 2011
Days to Decision 218 days
Submission Type Special
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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