Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Bio-Rad Medical Diagnostics GmbH

The following data is part of a premarket notification filed by Bio-rad Medical Diagnostics Gmbh with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK190424
510k NumberBK190424
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich,  63303,  GM
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2019-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610522123919 BK190424 0
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