MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Modification To Bd Facscanto System With Bd Facscanto Clinical Software.

Pre-market Notification Details

Device IDK050191
510k NumberK050191
Device Name:MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
ClassificationAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Applicant BECTON DICKINSON & CO. 2350 Qume Drive San Jose,  CA  95131
ContactCarter Navarro
CorrespondentCarter Navarro
BECTON DICKINSON & CO. 2350 Qume Drive San Jose,  CA  95131
Product CodePER  
CFR Regulation Number862.2750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-27
Decision Date2005-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382906641229 K050191 000
00382906641199 K050191 000
00382906641144 K050191 000

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