Cleared Traditional

EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT

K111036 · Medica Corporation · Chemistry

Jul 2011

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K111036 is an FDA 510(k) clearance for the EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on July 12, 2011, 89 days after receiving the submission on April 14, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K111036 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2011
Decision Date	July 12, 2011
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475