SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

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-100i Automated Urine Cell Analyzer.

Pre-market Notification Details

Device IDK053135
510k NumberK053135
Device Name:SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-08
Decision Date2006-01-04
Summary:summary

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