FACS LOADER 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 Facs Loader System.

Pre-market Notification Details

Device IDK953302
510k NumberK953302
Device Name:FACS LOADER SYSTEM
ClassificationCounter, Differential Cell
Applicant BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose,  CA  95131 -1807
ContactAnna M Longwell
CorrespondentAnna M Longwell
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 Received1995-07-14
Decision Date1995-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903365746 K953302 000

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