Cleared Traditional

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

K100937 · I-Sens, Inc. · Chemistry
Dec 2010
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K100937 is an FDA 510(k) clearance for the PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE, 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 December 21, 2010, 260 days after receiving the submission on April 5, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K100937 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2010
Decision Date December 21, 2010
Days to Decision 260 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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