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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 K230493
Device Name BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Katherine Kenner Lemus
Correspondent
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Katherine Kenner Lemus
Regulation Number862.1675
Classification Product Code
GIM  
Date Received02/23/2023
Decision Date 11/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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