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FDA 510(k)

SERAQUEST TOXOPLASMA IGG

K-Number: K960092 · 1996-06-17

ApplicantQuest Intl., Inc.
Decision Date1996-06-17
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST TOXOPLASMA IGG 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 1996-06-17 under 510(k) number K960092. 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 IGG?

SERAQUEST TOXOPLASMA IGG is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Quest Intl., Inc.. The 510(k) number is K960092.

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

SERAQUEST TOXOPLASMA IGG received FDA 510(k) clearance on 1996-06-17, under 510(k) number K960092.

Who is the listed applicant for SERAQUEST TOXOPLASMA IGG?

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 IGG?

The FDA product code for SERAQUEST TOXOPLASMA IGG 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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