Cleared Special

ACE MAGNESIUM REGENT

K122302 · Alfa Wassermann Diagnostics Technologies, LLC · Chemistry
Aug 2012
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K122302 is an FDA 510(k) clearance for the ACE MAGNESIUM REGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Alfa Wassermann Diagnostics Technologies, LLC (West Caldwell, US). The FDA issued a Cleared decision on August 27, 2012, 26 days after receiving the submission on August 1, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K122302 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2012
Decision Date August 27, 2012
Days to Decision 26 days
Submission Type Special
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