SYSMEX MODEL UF1000I

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 Model Uf1000i.

Pre-market Notification Details

Device IDK070910
510k NumberK070910
Device Name:SYSMEX MODEL UF1000I
ClassificationCounter, Urine Particle
Applicant SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
ContactNina M Gamperling
CorrespondentNina M Gamperling
SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
Product CodeLKM  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-02
Decision Date2007-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562408535 K070910 000

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