Cleared Traditional

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7

K063208 · Diagnostic Chemicals , Ltd. · Chemistry
Jan 2007
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K063208 is an FDA 510(k) clearance for the MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on January 19, 2007, 88 days after receiving the submission on October 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K063208 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2006
Decision Date January 19, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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