Cleared Special

EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

K100673 · Medica Corp. · Chemistry
Apr 2010
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K100673 is an FDA 510(k) clearance for the EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on April 6, 2010, 28 days after receiving the submission on March 9, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K100673 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2010
Decision Date April 06, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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