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FDA 510(k)

Lead-free Chemical Indicators for Steam Sterilization

K-Number: K181788 · 2019-03-01

ApplicantKem Medical Products Corp.
Decision Date2019-03-01
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Lead-free Chemical Indicators for Steam Sterilization is a medical device manufactured by Kem Medical Products Corp.. It received FDA 510(k) clearance on 2019-03-01 under approval number K181788. 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 Lead-free Chemical Indicators for Steam Sterilization?

Lead-free Chemical Indicators for Steam Sterilization is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Kem Medical Products Corp.. The 510(k) number is K181788.

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

Lead-free Chemical Indicators for Steam Sterilization received FDA 510(k) clearance on 2019-03-01, under approval number K181788.

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

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

What is the FDA product code for Lead-free Chemical Indicators for Steam Sterilization?

The FDA product code for Lead-free Chemical Indicators for Steam Sterilization is JOJ.

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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