SYSMEX R-500

Counter, Cell, Automated (particle Counter)

SYSMEX CORPORATION OF AMERICA

The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Sysmex R-500.

Pre-market Notification Details

Device IDK001683
510k NumberK001683
Device Name:SYSMEX R-500
ClassificationCounter, Cell, Automated (particle Counter)
Applicant SYSMEX CORPORATION OF AMERICA ONE WILDLIFE WAY Long Grove,  IL  60047 -9596
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX CORPORATION OF AMERICA ONE WILDLIFE WAY Long Grove,  IL  60047 -9596
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-01
Decision Date2000-08-21

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