Cleared Special

EASYRA CREATININE REAGENT

K123586 · Medica Corporation · Chemistry
May 2013
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K123586 is an FDA 510(k) clearance for the EASYRA CREATININE REAGENT, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on May 15, 2013, 175 days after receiving the submission on November 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K123586 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2012
Decision Date May 15, 2013
Days to Decision 175 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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