Cleared Traditional

FIA Blood Glucose Monitoring System (G2)

K131173 · Hmd Biomedical, Inc. · Chemistry
Sep 2014
Decision
511d
Days
Class 2
Risk

About This 510(k) Submission

K131173 is an FDA 510(k) clearance for the FIA Blood Glucose Monitoring System (G2), a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on September 18, 2014, 511 days after receiving the submission on April 25, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K131173 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2013
Decision Date September 18, 2014
Days to Decision 511 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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