FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET

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 Facscomp Software And Calibrite Beads For Use In Flow Cytometer Instrument Set.

Pre-market Notification Details

Device IDK973483
510k NumberK973483
Device Name:FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
ClassificationCounter, Differential Cell
Applicant BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose,  CA  95131 -1807
ContactCindy Morrow
CorrespondentCindy Morrow
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 Received1997-09-15
Decision Date1998-02-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903404872 K973483 000

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