FDA 510(k)

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

K-Number: K213953 · 2023-07-17

Decision Date2023-07-17

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K213953. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes?

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K213953.

When did BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes receive FDA 510(k) clearance?

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes received FDA 510(k) clearance on 2023-07-17, under 510(k) number K213953.

Who is the listed applicant for BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes?

The FDA product code for BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes is JKA.

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Other records listing Becton, Dickinson and Company as applicant

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

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Related Devices (Code: JKA)

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.