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FDA 510(k)

Revital-Ox PAA High Level Disinfectant Chemical Indicator

K-Number: K230558 · 2023-07-17

ApplicantSTERIS Corporation
Decision Date2023-07-17
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Revital-Ox PAA High Level Disinfectant Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230558. 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 Revital-Ox PAA High Level Disinfectant Chemical Indicator?

Revital-Ox PAA High Level Disinfectant Chemical Indicator is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is STERIS Corporation. The 510(k) number is K230558.

When did Revital-Ox PAA High Level Disinfectant Chemical Indicator receive FDA 510(k) clearance?

Revital-Ox PAA High Level Disinfectant Chemical Indicator received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230558.

Who is the listed applicant for Revital-Ox PAA High Level Disinfectant Chemical Indicator?

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 Revital-Ox PAA High Level Disinfectant Chemical Indicator?

The FDA product code for Revital-Ox PAA High Level Disinfectant Chemical Indicator is JOJ.

Other records listing STERIS Corporation as applicant

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K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

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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 ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

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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