FDA 510(k)

Rapicide PA High-Level Disinfectant Test Strips

K-Number: K152394 · 2016-03-11

Decision Date2016-03-11

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Rapicide PA High-Level Disinfectant Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K152394. 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 Rapicide PA High-Level Disinfectant Test Strips?

Rapicide PA High-Level Disinfectant Test Strips is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Medivators, Inc.. The 510(k) number is K152394.

When did Rapicide PA High-Level Disinfectant Test Strips receive FDA 510(k) clearance?

Rapicide PA High-Level Disinfectant Test Strips received FDA 510(k) clearance on 2016-03-11, under 510(k) number K152394.

Who is the listed applicant for Rapicide PA High-Level Disinfectant Test Strips?

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

What is the FDA product code for Rapicide PA High-Level Disinfectant Test Strips?

The FDA product code for Rapicide PA High-Level Disinfectant Test Strips is JOJ.

Other records listing Medivators, Inc. as applicant

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Related Devices (Code: JOJ)

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 K250172Green 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.