Cleared Traditional

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

K053135 · Sysmex America, Inc. · Pathology
Jan 2006
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K053135 is an FDA 510(k) clearance for the SYSMEX UF-100I AUTOMATED URINE CELL 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 January 4, 2006, 57 days after receiving the submission on November 8, 2005. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K053135 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2005
Decision Date January 04, 2006
Days to Decision 57 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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