Cleared Traditional

BD Vacutainer? Serum Separator (SST?) Blood Collection Tubes

K230855 · Becton, Dickinson and Company · Chemistry
Dec 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K230855 is an FDA 510(k) clearance for the BD Vacutainer? Serum Separator (SST?) Blood Collection 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 December 20, 2023, 267 days after receiving the submission on March 28, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K230855 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2023
Decision Date December 20, 2023
Days to Decision 267 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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