Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) 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. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K152422.

When did FREND™ Free T4 Test System receive FDA 510(k) clearance?

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

Who is the listed applicant for FREND™ Free T4 Test System?

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

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 records listing Nanoentek USA, Inc. 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.

K162378FREND PSA PLUS (reagent cartridge)K162754FREND Vitamin D Test SystemK153577FREND Testosterone Test System

Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott Laboratories

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.

↑