Cleared Traditional

Atellica CH Magnesium (Mg)

K162399 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jan 2017
Decision
146d
Days
Class 1
Risk

About This 510(k) Submission

K162399 is an FDA 510(k) clearance for the Atellica CH Magnesium (Mg), a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on January 19, 2017, 146 days after receiving the submission on August 26, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K162399 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2016
Decision Date January 19, 2017
Days to Decision 146 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