Cleared Special

EASTLYTE NA/K/CA/PH

K112788 · Medica Corp. · Chemistry
Oct 2011
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K112788 is an FDA 510(k) clearance for the EASTLYTE NA/K/CA/PH, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on October 20, 2011, 24 days after receiving the submission on September 26, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K112788 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2011
Decision Date October 20, 2011
Days to Decision 24 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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