Cleared Special

CareSens S Clear BT Blood Glucose Monitoring System

K192859 · I-Sens, Inc. · Chemistry
Jan 2020
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K192859 is an FDA 510(k) clearance for the CareSens S Clear BT 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 January 24, 2020, 112 days after receiving the submission on October 4, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K192859 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2019
Decision Date January 24, 2020
Days to Decision 112 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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