Cleared Traditional

MAGNESIUM ASSAY

K111915 · Sekisui Diagnostics P.E.I., Inc. · Chemistry
Dec 2011
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K111915 is an FDA 510(k) clearance for the MAGNESIUM ASSAY, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Sekisui Diagnostics P.E.I., Inc. (Prince Edward Island, CA). The FDA issued a Cleared decision on December 2, 2011, 149 days after receiving the submission on July 6, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K111915 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2011
Decision Date December 02, 2011
Days to Decision 149 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