Cleared Traditional

DIMENSION EXL WITH LM SYSTEM

K130276 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2013
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K130276 is an FDA 510(k) clearance for the DIMENSION EXL WITH LM SYSTEM, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on March 22, 2013, 45 days after receiving the submission on February 5, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K130276 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2013
Decision Date March 22, 2013
Days to Decision 45 days
Submission Type Traditional
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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