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FDA 510(k)

FREND Testosterone Test System

K-Number: K153577 · 2016-10-14

ApplicantNanoentek USA, Inc.
Decision Date2016-10-14
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREND Testosterone 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 2016-10-14 under 510(k) number K153577. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREND Testosterone Test System?

FREND Testosterone Test System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K153577.

When did FREND Testosterone Test System receive FDA 510(k) clearance?

FREND Testosterone Test System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K153577.

Who is the listed applicant for FREND Testosterone 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 Testosterone Test System?

The FDA product code for FREND Testosterone Test System is CDZ.

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 SystemK152422FREND™ Free T4 Test System

Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, Inc.

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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