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FDA 510(k)

Sterilucent VH2O2 Chemical Indicators

K-Number: K191999 · 2019-10-21

ApplicantSterilucent, Inc.
Decision Date2019-10-21
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilucent VH2O2 Chemical Indicators is a medical device manufactured by Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-10-21 under approval number K191999. 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 Sterilucent VH2O2 Chemical Indicators?

Sterilucent VH2O2 Chemical Indicators is a medical device that received FDA 510(k) clearance on 2019-10-21. It is manufactured by Sterilucent, Inc.. The 510(k) number is K191999.

When was Sterilucent VH2O2 Chemical Indicators approved by the FDA?

Sterilucent VH2O2 Chemical Indicators received FDA 510(k) clearance on 2019-10-21, under approval number K191999.

What company makes Sterilucent VH2O2 Chemical Indicators?

Sterilucent VH2O2 Chemical Indicators is manufactured by Sterilucent, Inc..

What is the FDA product code for Sterilucent VH2O2 Chemical Indicators?

The FDA product code for Sterilucent VH2O2 Chemical Indicators is JOJ.

Other Devices by Sterilucent, Inc.

K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device K190005Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

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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