Cleared Traditional

MTM301 Blood Glucose and Ketone Monitoring System

K202534 · Apex BioTechnology Corp. · Chemistry
Apr 2022
Decision
582d
Days
Class 2
Risk

About This 510(k) Submission

K202534 is an FDA 510(k) clearance for the MTM301 Blood Glucose and Ketone Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 6, 2022, 582 days after receiving the submission on September 1, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K202534 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2020
Decision Date April 06, 2022
Days to Decision 582 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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