SPECTRA OPTIA R APHERESIS SYSTEM

Separator, Automated, Blood Cell And Plasma, Therapeutic

CARIDIANBCT, INC.

The following data is part of a premarket notification filed by Caridianbct, Inc. with the FDA for Spectra Optia R Apheresis System.

Pre-market Notification Details

Device IDK103090
510k NumberK103090
Device Name:SPECTRA OPTIA R APHERESIS SYSTEM
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant CARIDIANBCT, INC. 10811 W. COLLINS AVE Lakewood,  CO  80215
ContactPatti Arndt
CorrespondentPatti Arndt
CARIDIANBCT, INC. 10811 W. COLLINS AVE Lakewood,  CO  80215
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-19
Decision Date2010-11-19
Summary:summary

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