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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 K231373
Device Name BD Vacutainer® K2 EDTA Blood Collection Tubes
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Pablo Martinez
Correspondent
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Brice Biggins
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
GIM  
Date Received05/12/2023
Decision Date 02/02/2024
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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