Cleared Traditional

EasyStat 300

K220396 · Medica Corporation · Chemistry
Sep 2023
Decision
592d
Days
Class 2
Risk

About This 510(k) Submission

K220396 is an FDA 510(k) clearance for the EasyStat 300, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on September 26, 2023, 592 days after receiving the submission on February 11, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K220396 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2022
Decision Date September 26, 2023
Days to Decision 592 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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