FDA 510(k)

Lead-free Chemical Indicators for Steam Sterilization

Номер K: K181788 · 2019-03-01

Дата решения2019-03-01

Код продуктаJOJ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Lead-free Chemical Indicators for Steam Sterilization is the device name listed in this FDA 510(k) record. The listed applicant is Kem Medical Products Corp.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K181788. 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 Lead-free Chemical Indicators for Steam Sterilization?

Lead-free Chemical Indicators for Steam Sterilization is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Kem Medical Products Corp.. The 510(k) number is K181788.

When did Lead-free Chemical Indicators for Steam Sterilization receive FDA 510(k) clearance?

Lead-free Chemical Indicators for Steam Sterilization received FDA 510(k) clearance on 2019-03-01, under 510(k) number K181788.

Who is the listed applicant for Lead-free Chemical Indicators for Steam Sterilization?

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

What is the FDA product code for Lead-free Chemical Indicators for Steam Sterilization?

The FDA product code for Lead-free Chemical Indicators for Steam Sterilization 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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