Cleared Traditional

TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA

K051969 · Ibl GmbH · Chemistry
Oct 2005
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K051969 is an FDA 510(k) clearance for the TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA, a Chromatographic/fluorometric Method, Catecholamines (Class I — General Controls, product code CHQ), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on October 3, 2005, 75 days after receiving the submission on July 20, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number K051969 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2005
Decision Date October 03, 2005
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHQ — Chromatographic/fluorometric Method, Catecholamines
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1165

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