Cleared Traditional

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

K100060 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry

Dec 2010

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K100060 is an FDA 510(k) clearance for the EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on December 15, 2010, 338 days after receiving the submission on January 11, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K100060 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2010
Decision Date	December 15, 2010
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement