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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 a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-07-17 under approval 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. It is manufactured by STERIS Corporation. The 510(k) number is K230558.

When was Revital-Ox PAA High Level Disinfectant Chemical Indicator approved by the FDA?

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

What company makes Revital-Ox PAA High Level Disinfectant Chemical Indicator?

Revital-Ox PAA High Level Disinfectant Chemical Indicator is manufactured by STERIS Corporation.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40035968 Chemical Characterization in Medical Device Evaluation: Current Practices, Regulatory Requirements, and Future Directions. Annals of biomedical engineering (2025)

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Related Devices (Code: JOJ)

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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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