BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

Counter, Differential Cell

BD Biosciences

The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Facscanto Ii Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962.

Pre-market Notification Details

Device IDK062087
510k NumberK062087
Device Name:BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
ClassificationCounter, Differential Cell
Applicant BD Biosciences 2350 QUME DR. San Jose,  CA  95131 -1807
ContactCarter Navarro
CorrespondentCarter Navarro
BD Biosciences 2350 QUME DR. San Jose,  CA  95131 -1807
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-24
Decision Date2006-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382906578808 K062087 000
00382906577696 K062087 000
00382903420650 K062087 000
00382903389605 K062087 000
00382906641243 K062087 000
00382906641106 K062087 000

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