Cleared Special

GlucoLeader Enhance 2 Blood Glucose Monitoring System

K212248 · Hmd Biomedical, Inc. · Chemistry
Aug 2022
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K212248 is an FDA 510(k) clearance for the GlucoLeader Enhance 2 Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Hmd Biomedical, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on August 29, 2022, 406 days after receiving the submission on July 19, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K212248 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2021
Decision Date August 29, 2022
Days to Decision 406 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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