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FDA 510(k)

FREND™ Free T4 Test System

K-Number: K152422 · 2016-02-17

ApplicantNanoentek USA, Inc.
Decision Date2016-02-17
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREND™ Free T4 Test System is a medical device manufactured by Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-02-17 under approval number K152422. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREND™ Free T4 Test System?

FREND™ Free T4 Test System is a medical device that received FDA 510(k) clearance on 2016-02-17. It is manufactured by Nanoentek USA, Inc.. The 510(k) number is K152422.

When was FREND™ Free T4 Test System approved by the FDA?

FREND™ Free T4 Test System received FDA 510(k) clearance on 2016-02-17, under approval number K152422.

What company makes FREND™ Free T4 Test System?

FREND™ Free T4 Test System is manufactured by Nanoentek USA, Inc..

What is the FDA product code for FREND™ Free T4 Test System?

The FDA product code for FREND™ Free T4 Test System is CEC.

Other Devices by Nanoentek USA, Inc.

K153577FREND Testosterone Test System K162378FREND PSA PLUS (reagent cartridge) K162754FREND Vitamin D Test System

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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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