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 a medical device manufactured by U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2018-02-22 under approval 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. It is manufactured by U&U Medical Technology Co, Ltd.. The 510(k) number is K171823.

When was U&U Indicator tape and strip approved by the FDA?

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

What company makes U&U Indicator tape and strip?

U&U Indicator tape and strip is manufactured by U&U Medical Technology Co, Ltd..

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 Devices by U&U Medical Technology Co, Ltd.

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

Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, Inc.

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.