FDA 510(k)

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

Номер K: K151482 · 2016-02-26

Дата решения2016-02-26

Код продуктаFRC

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Bcr Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K151482. 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 BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Bcr Diagnostics, Inc.. The 510(k) number is K151482.

When did BCR-30-min BI™ and RBIP-ST30™ Readout Accessory receive FDA 510(k) clearance?

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory received FDA 510(k) clearance on 2016-02-26, under 510(k) number K151482.

Who is the listed applicant for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

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

What is the FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory?

The FDA product code for BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 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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