Cleared Traditional

EASYRA CLINICAL CHEMISTRY ANALYZER

K070057 · Medica Corp. · Chemistry
Aug 2007
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K070057 is an FDA 510(k) clearance for the EASYRA CLINICAL CHEMISTRY ANALYZER, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on August 30, 2007, 237 days after receiving the submission on January 5, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K070057 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2007
Decision Date August 30, 2007
Days to Decision 237 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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