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FDA 510(k)

Elecsys FT4 III

K-Number: K181233 · 2018-09-18

ApplicantRoche Diagnostics
Decision Date2018-09-18
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys FT4 III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181233. 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 Elecsys FT4 III?

Elecsys FT4 III is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Roche Diagnostics. The 510(k) number is K181233.

When did Elecsys FT4 III receive FDA 510(k) clearance?

Elecsys FT4 III received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181233.

Who is the listed applicant for Elecsys FT4 III?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys FT4 III?

The FDA product code for Elecsys FT4 III is CEC.

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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.K173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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