Cleared Special

SMARTLOG DIABETES MANAGEMENT SOFTWARE

K133346 · I-Sens, Inc. · Chemistry
Dec 2013
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K133346 is an FDA 510(k) clearance for the SMARTLOG DIABETES MANAGEMENT SOFTWARE, 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 December 19, 2013, 50 days after receiving the submission on October 30, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K133346 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2013
Decision Date December 19, 2013
Days to Decision 50 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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