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 IDBK120065
510k NumberBK120065
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Haemonetics Corporation 400 Wood Road Braintree,  MA  02184
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2012-11-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30812747011987 BK120065 0

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