FDA 510(k)

NATtrol BD MAX Vaginal Panel External Controls

Номер K: K201403 · 2022-02-02

ЗаявительZeptometrix

Дата решения2022-02-02

Код продуктаPMN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

NATtrol BD MAX Vaginal Panel External Controls is the device name listed in this FDA 510(k) record. The listed applicant is Zeptometrix. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K201403. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the NATtrol BD MAX Vaginal Panel External Controls?

NATtrol BD MAX Vaginal Panel External Controls is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Zeptometrix. The 510(k) number is K201403.

When did NATtrol BD MAX Vaginal Panel External Controls receive FDA 510(k) clearance?

NATtrol BD MAX Vaginal Panel External Controls received FDA 510(k) clearance on 2022-02-02, under 510(k) number K201403.

Who is the listed applicant for NATtrol BD MAX Vaginal Panel External Controls?

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

What is the FDA product code for NATtrol BD MAX Vaginal Panel External Controls?

The FDA product code for NATtrol BD MAX Vaginal Panel External Controls is PMN.

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: PMN)

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLC K254166MDx-Chex for BCNStreck K254167MDx-Chex for BCYStreck, LLC K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

Официальный источник

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