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FDA 510(k)

FT4 RADIOIMMUNOASSAY

K-Number: K934012 · 1993-11-16

ApplicantImmunotech S.A.
Decision Date1993-11-16
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FT4 RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech S.A.. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K934012. 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 FT4 RADIOIMMUNOASSAY?

FT4 RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Immunotech S.A.. The 510(k) number is K934012.

When did FT4 RADIOIMMUNOASSAY receive FDA 510(k) clearance?

FT4 RADIOIMMUNOASSAY received FDA 510(k) clearance on 1993-11-16, under 510(k) number K934012.

Who is the listed applicant for FT4 RADIOIMMUNOASSAY?

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

What is the FDA product code for FT4 RADIOIMMUNOASSAY?

The FDA product code for FT4 RADIOIMMUNOASSAY 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.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott 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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