Cleared Special

DIMENSION CLINICAL CHEMISTRY SYSTEM

K112999 · Siemens Healthcare Diagnostics · Chemistry
Nov 2011
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K112999 is an FDA 510(k) clearance for the DIMENSION CLINICAL CHEMISTRY SYSTEM, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 22, 2011, 46 days after receiving the submission on October 7, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K112999 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2011
Decision Date November 22, 2011
Days to Decision 46 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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