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Manual Blood Grouping And Antibody Test Systems

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 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK170066
510k NumberBK170066
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationManual Blood Grouping And Antibody Test Systems
Applicant Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich,  63303,  GM
Product CodePBC  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-19
Decision Date2017-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07611969226344 BK170066 0

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