FDA 510(k)

3MTM AttestTM Рапид 5 Паровой-Плюс Тест Пакет

Номер K: K200536 · 2020-06-01

Заявитель3M Complany

Дата решения2020-06-01

Код продуктаFRC

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is 3M Complany. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K200536. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is 3M Complany. The 510(k) number is K200536.

When did 3MTM AttestTM Rapid 5 Steam-Plus Test Pack receive FDA 510(k) clearance?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack received FDA 510(k) clearance on 2020-06-01, under 510(k) number K200536.

Who is the listed applicant for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA 510(k) record lists 3M Complany as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack is FRC.

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: FRC)

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation K251122Terragene® Bionova® BT20 Biological IndicatorTerragene K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)Steris K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS Corporation K250061Celerity IncubatorSTERIS Corporation

Официальный источник

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