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FDA 510(k)

Kem Medical Lead-free Chemical Indicators for Steam Sterilization

K-Number: K241836 · 2024-09-30

ApplicantKem Medical Products Corporation
Decision Date2024-09-30
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is a medical device manufactured by Kem Medical Products Corporation. It received FDA 510(k) clearance on 2024-09-30 under approval number K241836. 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 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. It is manufactured by Kem Medical Products Corporation. The 510(k) number is K241836.

When was Kem Medical Lead-free Chemical Indicators for Steam Sterilization approved by the FDA?

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

What company makes Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is manufactured by Kem Medical Products Corporation.

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.

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Related PubMed Literature

PMID: 40685851 A Comprehensive Review of Clinical Studies on Bacterial Cellulose: From the Earliest Uses to Contemporary Innovations. Advanced healthcare materials (2025) PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025) PMID: 40035968 Chemical Characterization in Medical Device Evaluation: Current Practices, Regulatory Requirements, and Future Directions. Annals of biomedical engineering (2025) PMID: 39936568 2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: "Medical Device Safety Assessment: Pathology and Toxicology Perspective". Toxicologic pathology (2025)

Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, Inc.

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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