SYSMEX UF-100

Counter, Urine Particle

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Uf-100.

Pre-market Notification Details

Device IDK961054
510k NumberK961054
Device Name:SYSMEX UF-100
ClassificationCounter, Urine Particle
Applicant SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
Product CodeLKM  
Subsequent Product CodeJIW
Subsequent Product CodeJJW
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-18
Decision Date1996-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562408542 K961054 000

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