Cleared Traditional

CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

K130696 · I-Sens, Inc. · Chemistry
Aug 2013
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K130696 is an FDA 510(k) clearance for the CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by I-Sens, Inc. (Seoul, Korea, KR). The FDA issued a Cleared decision on August 21, 2013, 160 days after receiving the submission on March 14, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K130696 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2013
Decision Date August 21, 2013
Days to Decision 160 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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