SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE— 510(k) K080887

Name: FDA 510(k) clearance K080887
Creator: U.S. Food and Drug Administration
Published: 2008-05-02

Substantially Equivalent

Sysmex America, Inc.

FDA 510(k) clearance K080887 for SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE, Substantially Equivalent on 2008-05-02. Applicant: Sysmex America, Inc.. Device class: 2.

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code LKM
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2008-03-31
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K080887

K-number listed on FDA's recall record

Z-0949-2014 — The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.Class II·Terminated·Sysmex America, Inc.·20130331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080887.

Data sourced from openFDA. This site is unofficial and independent of the FDA.