SYSMEX SE/RAM-1

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 Se/ram-1.

Pre-market Notification Details

Device IDK964375
510k NumberK964375
Device Name:SYSMEX SE/RAM-1
ClassificationCounter, Cell, Automated (particle Counter)
Applicant SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
ContactCatherine M Trester, Mt(ascp)
CorrespondentCatherine M Trester, Mt(ascp)
SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
Product CodeGKL  
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-01
Decision Date1997-03-13
Summary:summary

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