Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

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 Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK900015
510k NumberBK900015
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant I. B. G. Systems Inc. p.o. Box 5306 Laytonsville,  MD  20882
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-02
Decision Date1990-09-20

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