Cleared Traditional

OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

K062862 · Olympus America, Inc. · Chemistry
Apr 2007
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K062862 is an FDA 510(k) clearance for the OLYMPUS URIC ACID REAGENT, MODEL OSR6X98, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on April 6, 2007, 193 days after receiving the submission on September 25, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K062862 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2006
Decision Date April 06, 2007
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KNK — Acid, Uric, Uricase (colorimetric)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

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