Cleared Traditional

ATAC PAK MAGNESIUM REAGENT

K030010 · Elan Diagnostics · Chemistry
Mar 2003
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K030010 is an FDA 510(k) clearance for the ATAC PAK MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on March 10, 2003, 67 days after receiving the submission on January 2, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K030010 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2003
Decision Date March 10, 2003
Days to Decision 67 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

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