Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

STRATEC Biomedical UK Limited

The following data is part of a premarket notification filed by Stratec Biomedical Uk Limited with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK160124
510k NumberBK160124
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant STRATEC Biomedical UK Limited third Ave, Centrum 100 burton Upon Trent Straffordshire,  DE14 2WD,  UK
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-27
Decision Date2017-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060496770028 BK160124 0

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