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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

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

FDA 510(k) source

510(k) number
K252344
Applicant
Becton, Dickinson and Company
Decision date
Oct 16, 2026
Date received
Jul 28, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
JKA
Device type
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class
Class II
Regulation
21 CFR 862.1675
Advisory committee
Clinical Chemistry
Statement or summary
Summary
Third party
N
Location
Franklin Lakes, NJ, US