Cleared Traditional

Randox RX Daytona Plus Magnesium (MG)

K162200 · Randox Laboratories, Ltd. · Chemistry
Apr 2017
Decision
266d
Days
Class 1
Risk

About This 510(k) Submission

K162200 is an FDA 510(k) clearance for the Randox RX Daytona Plus Magnesium (MG), a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on April 28, 2017, 266 days after receiving the submission on August 5, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K162200 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2016
Decision Date April 28, 2017
Days to Decision 266 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