Cleared Traditional

EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES

K090734 · Medica Corp. · Chemistry
Jul 2009
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K090734 is an FDA 510(k) clearance for the EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on July 17, 2009, 120 days after receiving the submission on March 19, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K090734 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2009
Decision Date July 17, 2009
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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