Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Haemonetics Corporation Software Solutions

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

Pre-market Notification Details

Device IDBK080038
510k NumberBK080038
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Haemonetics Corporation Software Solutions 1630 Industrial Park Street Covina,  CA  91722
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-05
Decision Date2008-09-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747012878 BK080038 0
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