Cleared Traditional

EON CALCIUM REGENT

K120626 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry
Aug 2012
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K120626 is an FDA 510(k) clearance for the EON CALCIUM REGENT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on August 22, 2012, 174 days after receiving the submission on March 1, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K120626 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2012
Decision Date August 22, 2012
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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