FDA 510(k)

MiniCollect K2E K2EDTA Tubes

N.º K: K182078 · 2019-01-25

Fecha de decisión2019-01-25

Código de productoJKA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

MiniCollect K2E K2EDTA Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182078. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MiniCollect K2E K2EDTA Tubes?

MiniCollect K2E K2EDTA Tubes is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K182078.

When did MiniCollect K2E K2EDTA Tubes receive FDA 510(k) clearance?

MiniCollect K2E K2EDTA Tubes received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182078.

Who is the listed applicant for MiniCollect K2E K2EDTA Tubes?

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

What is the FDA product code for MiniCollect K2E K2EDTA Tubes?

The FDA product code for MiniCollect K2E K2EDTA Tubes is JKA.

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Otros registros que enlistan a Greiner Bio-One Na, Inc. como solicitante

K180545VACUETTE SAFELINK Holder with male luer lock K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set K163436Greiner Vacuette Urine Count and Culture, Mannitol tube K160532Greiner Holdex

Dispositivos relacionados (Código: 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

Fuente oficial

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