Cleared Special

SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE

K080887 · Sysmex America, Inc. · Pathology
May 2008
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K080887 is an FDA 510(k) clearance for the SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE, 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 2, 2008, 32 days after receiving the submission on March 31, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K080887 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2008
Decision Date May 02, 2008
Days to Decision 32 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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