Cleared Special

ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION

K103278 · I-Sens, Inc. · Chemistry
Oct 2011
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K103278 is an FDA 510(k) clearance for the ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on October 28, 2011, 357 days after receiving the submission on November 5, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K103278 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2010
Decision Date October 28, 2011
Days to Decision 357 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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