Cleared Special

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

K220421 · Apex BioTechnology Corp. · Chemistry
Nov 2022
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K220421 is an FDA 510(k) clearance for the BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Apex BioTechnology Corp. (Hsinchu, CN). The FDA issued a Cleared decision on November 4, 2022, 263 days after receiving the submission on February 14, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K220421 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date November 04, 2022
Days to Decision 263 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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