FDA 510(k)

VACUETTE® QUICKSHIELD Complete (Plus)

Номер K: K233979 · 2024-07-19

ЗаявительGreiner Bio-One North America, Inc.

Дата решения2024-07-19

Код продуктаJKA

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

VACUETTE® QUICKSHIELD Complete (Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One North America, Inc.. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K233979. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VACUETTE® QUICKSHIELD Complete (Plus)?

VACUETTE® QUICKSHIELD Complete (Plus) is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Greiner Bio-One North America, Inc.. The 510(k) number is K233979.

When did VACUETTE® QUICKSHIELD Complete (Plus) receive FDA 510(k) clearance?

VACUETTE® QUICKSHIELD Complete (Plus) received FDA 510(k) clearance on 2024-07-19, under 510(k) number K233979.

Who is the listed applicant for VACUETTE® QUICKSHIELD Complete (Plus)?

The FDA 510(k) record lists Greiner Bio-One North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE® QUICKSHIELD Complete (Plus)?

The FDA product code for VACUETTE® QUICKSHIELD Complete (Plus) is JKA.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.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 K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Официальный источник

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