Cleared Special

ReliOn Premier Classic Blood Glucose Monitoring System

K192220 · I-Sens, Inc. · Chemistry
Dec 2019
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K192220 is an FDA 510(k) clearance for the ReliOn Premier Classic 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 13, 2019, 120 days after receiving the submission on August 15, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K192220 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2019
Decision Date December 13, 2019
Days to Decision 120 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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