FDA 510(k)

CHEMDI

K-Number: K801428 · 1980-08-13

Decision Date1980-08-13

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CHEMDI is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801428. 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 CHEMDI?

CHEMDI is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is American Sterilizer Co.. The 510(k) number is K801428.

When did CHEMDI receive FDA 510(k) clearance?

CHEMDI received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801428.

Who is the listed applicant for CHEMDI?

The FDA 510(k) record lists American Sterilizer Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEMDI?

The FDA product code for CHEMDI is JOJ.

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Other records listing American Sterilizer Co. as applicant

K943288AMSCO SQ240 SURGICAL LIGHT K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER K922485CHEMDI-VHP CHEMICAL INDICATOR K930493QUANTUM 3080 SURGICAL TABLE K905816ORTHOVISION TABLE K896674AMSCO QUANTUM LIGHT

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Related Devices (Code: JOJ)

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group K251991SafeSecure 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 Research K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation K243876VERIFY 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.