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Data Acquisition Software

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 IDBK160125
510k NumberBK160125
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
ClassificationData Acquisition Software
Applicant STRATEC Biomedical UK Limited third Ave, Centrum 100 burton Upon Trent Straffordshire,  DE14 2WD,  UK
Product CodePQQ  
CFR Regulation Number862.2570 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-28
Decision Date2017-04-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060496770011 BK160125 0

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