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

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• Device ID: BK180275
• 510k Number: BK180275
• Device Name: Automated Blood Grouping And Antibody Test Systems
• Classification: System, Test, Automated Blood Grouping And Antibody
• Applicant: Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich, 63303, GM
• Product Code: KSZ
• CFR Regulation Number: 864.9175 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-12
• Decision Date: 2019-03-21