Cleared Special

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE

K062316 · Dade Behring, Inc. · Chemistry
Sep 2006
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K062316 is an FDA 510(k) clearance for the DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on September 6, 2006, 28 days after receiving the submission on August 9, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K062316 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2006
Decision Date September 06, 2006
Days to Decision 28 days
Submission Type Special
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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