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FDA 510(k)

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100

K-Number: K111518 · 2012-10-03

ApplicantAdvanced Sterilization Products
Decision Date2012-10-03
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2012-10-03 under 510(k) number K111518. 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 STERRAD CHEMIAL INDICATOR STRIP MODEL 14100?

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is Advanced Sterilization Products. The 510(k) number is K111518.

When did STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 receive FDA 510(k) clearance?

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 received FDA 510(k) clearance on 2012-10-03, under 510(k) number K111518.

Who is the listed applicant for STERRAD CHEMIAL INDICATOR STRIP MODEL 14100?

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

What is the FDA product code for STERRAD CHEMIAL INDICATOR STRIP MODEL 14100?

The FDA product code for STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 is JOJ.

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Other records listing Advanced Sterilization Products 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.

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorK162007STERRAD NX SterilizerK160818STERRAD® NX Sterilizer with ALLClear™ TechnologyK160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyK151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

View all 49 devices →

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.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF 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 Corporation

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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