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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 K213670
Device Name BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Katherine Kenner Lemus
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Katherine Kenner Lemus
Regulation Number862.1675
Classification Product Code
GIM  
Date Received11/22/2021
Decision Date 08/25/2023
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
Predetermined Change
Control Plan Authorized		 No
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