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FDA 510(k)

A-GENT THYROZYME UPTAKE INHIBITOR ASSAY

K-Number: K800911 · 1980-06-20

ApplicantAbbott Laboratories
Decision Date1980-06-20
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-GENT THYROZYME UPTAKE INHIBITOR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K800911. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-GENT THYROZYME UPTAKE INHIBITOR ASSAY?

A-GENT THYROZYME UPTAKE INHIBITOR ASSAY is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Abbott Laboratories. The 510(k) number is K800911.

When did A-GENT THYROZYME UPTAKE INHIBITOR ASSAY receive FDA 510(k) clearance?

A-GENT THYROZYME UPTAKE INHIBITOR ASSAY received FDA 510(k) clearance on 1980-06-20, under 510(k) number K800911.

Who is the listed applicant for A-GENT THYROZYME UPTAKE INHIBITOR ASSAY?

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

What is the FDA product code for A-GENT THYROZYME UPTAKE INHIBITOR ASSAY?

The FDA product code for A-GENT THYROZYME UPTAKE INHIBITOR ASSAY is KHQ.

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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