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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 the device name listed in this FDA 510(k) record. The listed applicant is Kem Medical Products Corp.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) 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. The listed applicant is Kem Medical Products Corp.. The 510(k) number is K181788.

When did Lead-free Chemical Indicators for Steam Sterilization receive FDA 510(k) clearance?

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

Who is the listed applicant for Lead-free Chemical Indicators for Steam Sterilization?

The FDA 510(k) record lists Kem Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Kem Medical Products Corp. as applicant

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.

K241836Kem Medical Lead-free Chemical Indicators for Steam Sterilization

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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