FDA 510(k)

U&U Indicator tape and strip

K-Number: K171823 · 2018-02-22

ApplicantU&U Medical Technology Co, Ltd.

Decision Date2018-02-22

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

U&U Indicator tape and strip is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171823. 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 U&U Indicator tape and strip?

U&U Indicator tape and strip is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K171823.

When did U&U Indicator tape and strip receive FDA 510(k) clearance?

U&U Indicator tape and strip received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171823.

Who is the listed applicant for U&U Indicator tape and strip?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Indicator tape and strip?

The FDA product code for U&U Indicator tape and strip is JOJ.

Other records listing U&U Medical Technology Co, Ltd. 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.

K181508U&U Blood Collection Sets K160855U&U Enteral Syringe K152808U&U Insulin Syringe with/without Safety Retractable Device

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.