Cleared Traditional

BD Vacutainer? Trace Element K2EDTA Tubes, BD Vacutainer? Trace Element Serum Tubes

K213953 · Becton, Dickinson and Company · Chemistry
Jul 2023
Decision
577d
Days
Class 2
Risk

About This 510(k) Submission

K213953 is an FDA 510(k) clearance for the BD Vacutainer? Trace Element K2EDTA Tubes, BD Vacutainer? Trace Element Serum Tubes, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 17, 2023, 577 days after receiving the submission on December 17, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K213953 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2021
Decision Date July 17, 2023
Days to Decision 577 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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