Cleared Traditional

EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT

K072249 · Medica Corp. · Chemistry
Feb 2008
Decision
191d
Days
Class 1
Risk

About This 510(k) Submission

K072249 is an FDA 510(k) clearance for the EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Medica Corp. (Beverly, US). The FDA issued a Cleared decision on February 20, 2008, 191 days after receiving the submission on August 13, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K072249 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2007
Decision Date February 20, 2008
Days to Decision 191 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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