Cleared Traditional

EasyLyte Na/K/Cl/Ca Analyzer

K152327 · Medica Corporation · Chemistry
Dec 2016
Decision
471d
Days
Class 2
Risk

About This 510(k) Submission

K152327 is an FDA 510(k) clearance for the EasyLyte Na/K/Cl/Ca Analyzer, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on December 1, 2016, 471 days after receiving the submission on August 18, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K152327 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2015
Decision Date December 01, 2016
Days to Decision 471 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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