Cleared Traditional

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

K123677 · Siemens Healthcare Diagnostics · Chemistry
Mar 2013
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K123677 is an FDA 510(k) clearance for the DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL), 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 March 7, 2013, 97 days after receiving the submission on November 30, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K123677 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2012
Decision Date March 07, 2013
Days to Decision 97 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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