510(k) clearances

BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)

Becton, Dickinson and Company · Clinical Chemistry

K252344Substantially EquivalentTraditionalJKA
Open FDA's page for this record
Third party flag
N
City
Franklin Lakes
Advisory committee description
Clinical Chemistry
Address 1
1 Becton Dr.
Statement or summary
Summary
Product code
JKA
Zip code
07417
Applicant
Becton, Dickinson and Company
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
Advisory committee
CH
Contact
Matthew Tennen
K number
K252344
State
NJ
Date received
2025-07-28
Review advisory committee
CH
Postal code
07417
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty description
Clinical Chemistry
Regulation number
862.1675
Device class
2
Registration number
3008496607, 3030243919, 1055927, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 3015058854, 3019807891, 1058602, 3026940910, 3030626857, 3037918935, 1917413, 3008337059, 1055236, 3024537844, 3009518015, 3006425876, 9616567, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 9681835, 3013652330, 3044026004, 3001124136, 3019004087, 9680794, 8010026, 3014662855, 3035708936 +180 more
FEI number
3008496607, 3030243919, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 2828, 1000113359, 3003282181, 3015058854, 3019807891, 3000974732, 3026940910, 3030626857, 3037918935, 1000208624, 1917413, 3008337059, 3024537844, 3009518015, 3006425876, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 3000206435, 3013652330, 3044026004, 3002808075, 3001236905, 2649711, 3001124136, 3019004087 +180 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.