SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER

Counter, Differential Cell

SYSMEX AMERICA, INC.

The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Xe-2100dc Automated Hematology Analyzer.

Pre-market Notification Details

Device IDK051459
510k NumberK051459
Device Name:SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
ClassificationCounter, Differential Cell
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 CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-02
Decision Date2005-09-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.