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FDA 510(k)

Chemical Indicator for Steam

K-Number: K220778 · 2022-12-02

ApplicantTrue Indicating, LLC
Decision Date2022-12-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemical Indicator for Steam is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K220778. 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 Chemical Indicator for Steam?

Chemical Indicator for Steam is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is True Indicating, LLC. The 510(k) number is K220778.

When did Chemical Indicator for Steam receive FDA 510(k) clearance?

Chemical Indicator for Steam received FDA 510(k) clearance on 2022-12-02, under 510(k) number K220778.

Who is the listed applicant for Chemical Indicator for Steam?

The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chemical Indicator for Steam?

The FDA product code for Chemical Indicator for Steam is JOJ.

Other records listing True Indicating, LLC 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.

K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)K242860Type 5 Integrating Indicator for Steam (CSPN-15)K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)K210481Instant 20s IndicatorK200970Self-Contained Biological Indicator

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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