Automated Blood Cell Separator -Filtration

Separator, Automated, Blood Cell, Diagnostic

International Business Machines

The following data is part of a premarket notification filed by International Business Machines with the FDA for Automated Blood Cell Separator -filtration.

Pre-market Notification Details

Device IDBK820001
510k NumberBK820001
Device Name:Automated Blood Cell Separator -Filtration
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant International Business Machines Princeton,  NJ  08540
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-19
Decision Date1982-06-28

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