Cleared Special

EASYRA MG REAGENT, MODEL 10220

K092737 · Medica Corp. · Chemistry
Nov 2009
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K092737 is an FDA 510(k) clearance for the EASYRA MG REAGENT, MODEL 10220, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on November 17, 2009, 70 days after receiving the submission on September 8, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K092737 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2009
Decision Date November 17, 2009
Days to Decision 70 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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