Cleared Traditional

Magnesium

K181748 · Abbott Laboratories · Chemistry
Sep 2018
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K181748 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 September 12, 2018, 72 days after receiving the submission on July 2, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K181748 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2018
Decision Date September 12, 2018
Days to Decision 72 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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