Cleared Traditional

CareSens S Fit Blood Glucose Monitoring System

K180866 · I-Sens, Inc. · Chemistry
Aug 2018
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K180866 is an FDA 510(k) clearance for the CareSens S Fit 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 August 31, 2018, 151 days after receiving the submission on April 2, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K180866 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2018
Decision Date August 31, 2018
Days to Decision 151 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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