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

Counter, Urine Particle

SYSMEX AMERICA, INC.

The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Uf-1000i, Automated Urine Particle Analyzer With Urinalysis Wam Software.

Pre-market Notification Details

Device IDK080887
510k NumberK080887
Device Name:SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
ClassificationCounter, Urine Particle
Applicant SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
Product CodeLKM  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-31
Decision Date2008-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00664369000639 K080887 000

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