SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER

Counter, Cell, Automated (particle Counter)

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Kx-21, Automated Hematology Analyzer.

Pre-market Notification Details

Device IDK981761
510k NumberK981761
Device Name:SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
ClassificationCounter, Cell, Automated (particle Counter)
Applicant SYSMEX CORP. ONE WILDLIFE WAY Long Grove,  IL  60047 -9596
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX CORP. ONE WILDLIFE WAY Long Grove,  IL  60047 -9596
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-19
Decision Date1998-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562429219 K981761 000

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