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FDA 510(k)

FREND Vitamin D Test System

K-Number: K162754 · 2017-01-12

ApplicantNanoentek USA, Inc.
Decision Date2017-01-12
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREND Vitamin D 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 2017-01-12 under 510(k) number K162754. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREND Vitamin D Test System?

FREND Vitamin D Test System is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K162754.

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

FREND Vitamin D Test System received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162754.

Who is the listed applicant for FREND Vitamin D 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 Vitamin D Test System?

The FDA product code for FREND Vitamin D Test System is MRG.

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)K153577FREND Testosterone Test SystemK152422FREND™ Free T4 Test System

Related Devices (Code: MRG)

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.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.

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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