Cleared Traditional

NoCoding1 Plus Blood Glucose Monitoring System

K160742 · I-Sens, Inc. · Chemistry
Dec 2016
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K160742 is an FDA 510(k) clearance for the NoCoding1 Plus Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on December 16, 2016, 274 days after receiving the submission on March 17, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K160742 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2016
Decision Date December 16, 2016
Days to Decision 274 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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