Cleared Traditional

EasyStat 300

K220328 · Medica Corporation · Chemistry
Jul 2024
Decision
903d
Days
Class 2
Risk

About This 510(k) Submission

K220328 is an FDA 510(k) clearance for the EasyStat 300, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on July 26, 2024, 903 days after receiving the submission on February 4, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K220328 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2022
Decision Date July 26, 2024
Days to Decision 903 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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