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FDA 510(k)

RADIAS FREE T4 ENZYME IMMUNOASSAY

K-Number: K931110 · 1993-05-20

ApplicantBio-Rad
Decision Date1993-05-20
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIAS FREE T4 ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K931110. 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 RADIAS FREE T4 ENZYME IMMUNOASSAY?

RADIAS FREE T4 ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Bio-Rad. The 510(k) number is K931110.

When did RADIAS FREE T4 ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

RADIAS FREE T4 ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1993-05-20, under 510(k) number K931110.

Who is the listed applicant for RADIAS FREE T4 ENZYME IMMUNOASSAY?

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

What is the FDA product code for RADIAS FREE T4 ENZYME IMMUNOASSAY?

The FDA product code for RADIAS FREE T4 ENZYME IMMUNOASSAY is CEC.

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Other records listing Bio-Rad as applicant

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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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