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FDA 510(k)

DART DAILY AIR REMOVAL TEST

K-Number: K844512 · 1985-03-21

ApplicantAmerican Sterilizer Co.
Decision Date1985-03-21
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DART DAILY AIR REMOVAL TEST 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 1985-03-21 under 510(k) number K844512. 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 DART DAILY AIR REMOVAL TEST?

DART DAILY AIR REMOVAL TEST is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is American Sterilizer Co.. The 510(k) number is K844512.

When did DART DAILY AIR REMOVAL TEST receive FDA 510(k) clearance?

DART DAILY AIR REMOVAL TEST received FDA 510(k) clearance on 1985-03-21, under 510(k) number K844512.

Who is the listed applicant for DART DAILY AIR REMOVAL TEST?

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 DART DAILY AIR REMOVAL TEST?

The FDA product code for DART DAILY AIR REMOVAL TEST 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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