Cleared Traditional

Magnesium

K173294 · Abbott Laboratories · Chemistry
May 2018
Decision
214d
Days
Class 1
Risk

About This 510(k) Submission

K173294 is an FDA 510(k) clearance for the Magnesium, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 18, 2018, 214 days after receiving the submission on October 16, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K173294 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2017
Decision Date May 18, 2018
Days to Decision 214 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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