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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K230391
Device Name BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ 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 Lemus
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/14/2023
Decision Date 12/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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