Cleared Traditional

BD MiniDraw? Capillary Blood Collection System with BD MiniDraw? SST? Capillary Blood Collection Tube

K230391 · Becton, Dickinson and Company · Chemistry
Dec 2023
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K230391 is an FDA 510(k) clearance for the BD MiniDraw? Capillary Blood Collection System with BD MiniDraw? SST? Capillary Blood Collection Tube, 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 1, 2023, 290 days after receiving the submission on February 14, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K230391 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2023
Decision Date December 01, 2023
Days to Decision 290 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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