BD FACSCANTO SYSTEM

Counter, Differential Cell

BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Bd Facscanto System.

Pre-market Notification Details

Device IDK040725
510k NumberK040725
Device Name:BD FACSCANTO SYSTEM
ClassificationCounter, Differential Cell
Applicant BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose,  CA  95131 -1807
ContactKim Fonda
CorrespondentKim Fonda
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose,  CA  95131 -1807
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-22
Decision Date2004-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382906595287 K040725 000
00382906595232 K040725 000
00382906579256 K040725 000
00382906577740 K040725 000
00382906654212 K040725 000

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