Cleared Traditional

SYSMEX MODEL UF1000I

K070910 · Sysmex America, Inc. · Pathology
May 2007
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K070910 is an FDA 510(k) clearance for the SYSMEX MODEL UF1000I, a Counter, Urine Particle (Class II — Special Controls, product code LKM), submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 25, 2007, 53 days after receiving the submission on April 2, 2007. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K070910 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2007
Decision Date May 25, 2007
Days to Decision 53 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code LKM — Counter, Urine Particle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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