Cleared Traditional

EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

K100187 · Medica Corp. · Chemistry
May 2010
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K100187 is an FDA 510(k) clearance for the EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on May 5, 2010, 103 days after receiving the submission on January 22, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K100187 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2010
Decision Date May 05, 2010
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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