Cleared Special

SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER

K083002 · Sysmex America, Inc. · Pathology
Feb 2009
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K083002 is an FDA 510(k) clearance for the SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER, 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 February 3, 2009, 118 days after receiving the submission on October 8, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K083002 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2008
Decision Date February 03, 2009
Days to Decision 118 days
Submission Type Special
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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