Cleared Special

OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

K041793 · Olympus America, Inc. · Chemistry
Jul 2004
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K041793 is an FDA 510(k) clearance for the OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on July 16, 2004, 14 days after receiving the submission on July 2, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K041793 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2004
Decision Date July 16, 2004
Days to Decision 14 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JMO — Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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