Automated Cell-washing Centrifuge For Immune-hematology

Centrifuge, Cell-washing, Automated For Immuno-hematology

I. B. G. Systems Inc.

The following data is part of a premarket notification filed by I. B. G. Systems Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.

Pre-market Notification Details

Device IDBK920019
510k NumberBK920019
Device Name:Automated Cell-washing Centrifuge For Immune-hematology
ClassificationCentrifuge, Cell-washing, Automated For Immuno-hematology
Applicant I. B. G. Systems Inc. p.o. Box 5306 Laytonsville,  MD  20882
Product CodeKSN  
CFR Regulation Number864.9285 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-29
Decision Date1993-03-26

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