Centrifuge, Cell-Washing, Automated For Immunohematology

Centrifuge, Cell-washing, Automated For Immuno-hematology

International Equipment Company

The following data is part of a premarket notification filed by International Equipment Company with the FDA for Centrifuge, Cell-washing, Automated For Immunohematology.

Pre-market Notification Details

Device IDBK820020
510k NumberBK820020
Device Name:Centrifuge, Cell-Washing, Automated For Immunohematology
ClassificationCentrifuge, Cell-washing, Automated For Immuno-hematology
Applicant International Equipment Company 300 Second Avenue Needham Heights,  MA  02194
Product CodeKSN  
CFR Regulation Number864.9285 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-21
Decision Date1983-04-05

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