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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 the device name listed in this FDA 510(k) record. The listed applicant is Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-10-21 under 510(k) 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. The listed applicant is Sterilucent, Inc.. The 510(k) number is K191999.

When did Sterilucent VH2O2 Chemical Indicators receive FDA 510(k) clearance?

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

Who is the listed applicant for Sterilucent VH2O2 Chemical Indicators?

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

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

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

Other records listing Sterilucent, Inc. 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.

K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge DeviceK190005Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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