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FDA 510(k)

SERAQUEST ANTI-THYROGLOBULIN

K-Number: K023592 · 2003-01-06

ApplicantQuest Intl., Inc.
Decision Date2003-01-06
Product CodeDDC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERAQUEST ANTI-THYROGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Quest Intl., Inc.. It received FDA 510(k) clearance on 2003-01-06 under 510(k) number K023592. 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 SERAQUEST ANTI-THYROGLOBULIN?

SERAQUEST ANTI-THYROGLOBULIN is a medical device that received FDA 510(k) clearance on 2003-01-06. The listed applicant is Quest Intl., Inc.. The 510(k) number is K023592.

When did SERAQUEST ANTI-THYROGLOBULIN receive FDA 510(k) clearance?

SERAQUEST ANTI-THYROGLOBULIN received FDA 510(k) clearance on 2003-01-06, under 510(k) number K023592.

Who is the listed applicant for SERAQUEST ANTI-THYROGLOBULIN?

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

What is the FDA product code for SERAQUEST ANTI-THYROGLOBULIN?

The FDA product code for SERAQUEST ANTI-THYROGLOBULIN is DDC.

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Other records listing Quest Intl., Inc. 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.

K091260SERAQUEST EBV EA-D IGG TESTK033915MODIFICATION TO SERAQUEST EB VCA IGGK033780MODIFICATION TO SERAQUEST VCA IGMK023593SERAQUEST ANTI-THYROID PEROXIDASE (TPO)K003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEMK991975SERAQUEST EB NA IGG

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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.

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 ELISAMonobindK953066SERODIA ATGFujirebio America, 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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