Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Haemonetics Corporation

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

Pre-market Notification Details

Device IDBK200498
510k NumberBK200498
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Haemonetics Corporation 125 Summer St Boston,  MA  02110
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2020-10-02

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