Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Beckman Coulter, Inc.

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

Pre-market Notification Details

Device IDBK180292
510k NumberBK180292
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Beckman Coulter, Inc. 250 South Kraemer Blvd Brea,  CA  92821 US
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-03
Decision Date2020-05-07

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