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FDA 510(k)

CHEMDI STEAM & GAS STERILIZATION INDICA

K-Number: K823074 · 1982-11-08

ApplicantAmerican Sterilizer Co.
Decision Date1982-11-08
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEMDI STEAM & GAS STERILIZATION INDICA 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 1982-11-08 under 510(k) number K823074. 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 STEAM & GAS STERILIZATION INDICA?

CHEMDI STEAM & GAS STERILIZATION INDICA is a medical device that received FDA 510(k) clearance on 1982-11-08. The listed applicant is American Sterilizer Co.. The 510(k) number is K823074.

When did CHEMDI STEAM & GAS STERILIZATION INDICA receive FDA 510(k) clearance?

CHEMDI STEAM & GAS STERILIZATION INDICA received FDA 510(k) clearance on 1982-11-08, under 510(k) number K823074.

Who is the listed applicant for CHEMDI STEAM & GAS STERILIZATION INDICA?

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 STEAM & GAS STERILIZATION INDICA?

The FDA product code for CHEMDI STEAM & GAS STERILIZATION INDICA is JOJ.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

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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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