FDA 510(k)

Kawasumi Laboratories Blood Drawing Kit (BDK) System

Номер K: K172957 · 2018-09-28

Дата решения2018-09-28

Код продуктаKSB

Консультативный комитетHE

РешениеSubstantially Equivalent

Описание устройства

Kawasumi Laboratories Blood Drawing Kit (BDK) System is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K172957. The device is classified under product code KSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Kawasumi Laboratories Blood Drawing Kit (BDK) System?

Kawasumi Laboratories Blood Drawing Kit (BDK) System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K172957.

When did Kawasumi Laboratories Blood Drawing Kit (BDK) System receive FDA 510(k) clearance?

Kawasumi Laboratories Blood Drawing Kit (BDK) System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K172957.

Who is the listed applicant for Kawasumi Laboratories Blood Drawing Kit (BDK) System?

The FDA 510(k) record lists Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System?

The FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System is KSB.

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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Другие записи, где Kawasumi Laboratories, Inc. указан как заявитель

K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)K190233K-Shield Advantage Port Access Infusion Set (PAIS)

Официальный источник

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