Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Fujirebio America Inc.

The following data is part of a premarket notification filed by Fujirebio America Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK960092
510k NumberBK960092
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Fujirebio America Inc. 30 Two Bridges Road suite 250 Fairfield,  NJ  07004 US
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-11
Decision Date1998-10-28

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