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FDA 510(k)

GLOBULIN TEST, HUMAN THYROXINE BINDING

K-Number: K781225 · 1978-08-31

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1978-08-31
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLOBULIN TEST, HUMAN THYROXINE BINDING is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781225. 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 GLOBULIN TEST, HUMAN THYROXINE BINDING?

GLOBULIN TEST, HUMAN THYROXINE BINDING is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K781225.

When did GLOBULIN TEST, HUMAN THYROXINE BINDING receive FDA 510(k) clearance?

GLOBULIN TEST, HUMAN THYROXINE BINDING received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781225.

Who is the listed applicant for GLOBULIN TEST, HUMAN THYROXINE BINDING?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBULIN TEST, HUMAN THYROXINE BINDING?

The FDA product code for GLOBULIN TEST, HUMAN THYROXINE BINDING is CEE.

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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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