Cleared Special

GAL-1A Plus Blood Glucose Monitoring System

K213887 · Apex BioTechnology Corp. · Chemistry
Mar 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K213887 is an FDA 510(k) clearance for the GAL-1A Plus 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 March 29, 2022, 106 days after receiving the submission on December 13, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K213887 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2021
Decision Date March 29, 2022
Days to Decision 106 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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