FDA 510(k)

Kem Medical Lead-free Chemical Indicators for Steam Sterilization

Numéro K : K241836 · 2024-09-30

DemandeurKem Medical Products Corporation

Date de décision2024-09-30

Code produitJOJ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Kem Medical 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 Corporation. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241836. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Kem Medical Products Corporation. The 510(k) number is K241836.

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

Kem Medical Lead-free Chemical Indicators for Steam Sterilization received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241836.

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

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

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

The FDA product code for Kem Medical Lead-free Chemical Indicators for Steam Sterilization is JOJ.

Essais cliniques associés

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Dispositifs connexes (Code : 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

Source officielle

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