Cleared Special

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

K170614 · I-Sens, Inc. · Chemistry
Oct 2017
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K170614 is an FDA 510(k) clearance for the CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier 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 October 19, 2017, 232 days after receiving the submission on March 1, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K170614 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2017
Decision Date October 19, 2017
Days to Decision 232 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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