Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Harvest Technologies

The following data is part of a premarket notification filed by Harvest Technologies with the FDA for Automated Blood Cell Separators.

Pre-market Notification Details

Device IDBK100059
510k NumberBK100059
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Harvest Technologies 40 Grissom Road Plymouth,  MA  02360 US
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-22
Decision Date2010-11-18

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