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FDA 510(k)

THYROXINE-BINDING GLOBULIN RADIOUMMU

K-Number: K842010 · 1984-06-25

ApplicantNichols Institute Diagnostics
Decision Date1984-06-25
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE-BINDING GLOBULIN RADIOUMMU is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1984-06-25 under 510(k) number K842010. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYROXINE-BINDING GLOBULIN RADIOUMMU?

THYROXINE-BINDING GLOBULIN RADIOUMMU is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K842010.

When did THYROXINE-BINDING GLOBULIN RADIOUMMU receive FDA 510(k) clearance?

THYROXINE-BINDING GLOBULIN RADIOUMMU received FDA 510(k) clearance on 1984-06-25, under 510(k) number K842010.

Who is the listed applicant for THYROXINE-BINDING GLOBULIN RADIOUMMU?

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

What is the FDA product code for THYROXINE-BINDING GLOBULIN RADIOUMMU?

The FDA product code for THYROXINE-BINDING GLOBULIN RADIOUMMU is CEE.

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Other records listing Nichols Institute Diagnostics as applicant

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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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Related Devices (Code: CEE)

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.

K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer 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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