CELL-DYN RUBY SYSTEM

Counter, Differential Cell

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cell-dyn Ruby System.

Pre-market Notification Details

Device IDK061667
510k NumberK061667
Device Name:CELL-DYN RUBY SYSTEM
ClassificationCounter, Differential Cell
Applicant ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara,  CA  95054
ContactMichelle Roeding
CorrespondentMichelle Roeding
ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara,  CA  95054
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-14
Decision Date2006-07-10
Summary:summary

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