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FDA 510(k)

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)

K-Number: K874875 · 1988-03-24

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1988-03-24
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K874875. 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 CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)?

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K874875.

When did CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) receive FDA 510(k) clearance?

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) received FDA 510(k) clearance on 1988-03-24, under 510(k) number K874875.

Who is the listed applicant for CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)?

The FDA 510(k) record lists Boots-Celltech Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)?

The FDA product code for CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) is CEC.

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Other records listing Boots-Celltech Diagnostics, Inc. 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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