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Blood Establishment Computer Software And Accessories

STRATEC Biomedical UK Limited

The following data is part of a premarket notification filed by Stratec Biomedical Uk Limited 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 IDBK160071
510k NumberBK160071
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
ClassificationBlood Establishment Computer Software And Accessories
Applicant STRATEC Biomedical UK Limited third Ave, Centrum 100 burton Upon Trent Straffordshire,  DE14 2WD,  UK
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-11
Decision Date2017-10-30

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