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FDA 510(k)

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY

K-Number: K936010 · 1994-07-18

ApplicantBiomerica, Inc.
Decision Date1994-07-18
Product CodeDDC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K936010. The device is classified under product code DDC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY?

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Biomerica, Inc.. The 510(k) number is K936010.

When did THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-07-18, under 510(k) number K936010.

Who is the listed applicant for THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY?

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

What is the FDA product code for THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY?

The FDA product code for THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY is DDC.

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Related Devices (Code: DDC)

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.

K023592SERAQUEST ANTI-THYROGLOBULINQuest Intl., Inc.K012208ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895Beckman Coulter, Inc.K000363MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.Zeus Scientific, Inc.K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAMonobind

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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