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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vacuum sample, with anticoagulant
510(k) Number BK230980
Tradename BD Vacutainer K2EDTA Blood Collection Tubes
Device Name Tubes, Vacuum Sample, With Anticoagulant
Original Applicant
Becton, Dickinson & Company
7 loveton circle, mc 694
sparks,  MD  21152 0999
Regulation Number862.1675
Classification Product Code
GIM  
Date Received07/28/2023
Decision Date 04/17/2024
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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