Cleared Traditional

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE

K123320 · Siemens Healthcare Diagnostics · Chemistry
Feb 2013
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K123320 is an FDA 510(k) clearance for the DIMENSION AMMONIA FLEX REAGENT CARTRIDGE, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 15, 2013, 112 days after receiving the submission on October 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K123320 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2012
Decision Date February 15, 2013
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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