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FDA 510(k)

SERAQUEST TOXOPLASMA IGM

K-Number: K971672 · 1997-10-21

ApplicantQuest Intl., Inc.
Decision Date1997-10-21
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST TOXOPLASMA IGM 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 1997-10-21 under 510(k) number K971672. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST TOXOPLASMA IGM?

SERAQUEST TOXOPLASMA IGM is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Quest Intl., Inc.. The 510(k) number is K971672.

When did SERAQUEST TOXOPLASMA IGM receive FDA 510(k) clearance?

SERAQUEST TOXOPLASMA IGM received FDA 510(k) clearance on 1997-10-21, under 510(k) number K971672.

Who is the listed applicant for SERAQUEST TOXOPLASMA IGM?

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 TOXOPLASMA IGM?

The FDA product code for SERAQUEST TOXOPLASMA IGM is LGD.

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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)K023592SERAQUEST ANTI-THYROGLOBULINK003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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