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FDA 510(k)

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

K-Number: K251048 · 2025-05-02

ApplicantSTERIS Corporation
Decision Date2025-05-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K251048. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118?

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is STERIS Corporation. The 510(k) number is K251048.

When did Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 receive FDA 510(k) clearance?

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 received FDA 510(k) clearance on 2025-05-02, under 510(k) number K251048.

Who is the listed applicant for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118?

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

What is the FDA product code for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118?

The FDA product code for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 is JOJ.

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Other records listing STERIS Corporation as applicant

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure 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 ResearchK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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