FDA 510(k)

Green Card Bowie-Dick Test (BD115)

Номер K: K250172 · 2025-02-20

ЗаявительSteritec Products, Inc. (A Getinge Company)

Дата решения2025-02-20

Код продуктаJOJ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Green Card Bowie-Dick Test (BD115) is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc. (A Getinge Company). It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K250172. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Green Card Bowie-Dick Test (BD115)?

Green Card Bowie-Dick Test (BD115) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Steritec Products, Inc. (A Getinge Company). The 510(k) number is K250172.

When did Green Card Bowie-Dick Test (BD115) receive FDA 510(k) clearance?

Green Card Bowie-Dick Test (BD115) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K250172.

Who is the listed applicant for Green Card Bowie-Dick Test (BD115)?

The FDA 510(k) record lists Steritec Products, Inc. (A Getinge Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Green Card Bowie-Dick Test (BD115)?

The FDA product code for Green Card Bowie-Dick Test (BD115) is JOJ.

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: JOJ)

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim Research K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

Официальный источник

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