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FDA 510(k)

SERAQUEST MUMPS IGG

K-Number: K980059 · 1998-04-23

ApplicantQuest Intl., Inc.
Decision Date1998-04-23
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST MUMPS 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 1998-04-23 under 510(k) number K980059. The device is classified under product code LJY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST MUMPS IGG?

SERAQUEST MUMPS IGG is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Quest Intl., Inc.. The 510(k) number is K980059.

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

SERAQUEST MUMPS IGG received FDA 510(k) clearance on 1998-04-23, under 510(k) number K980059.

Who is the listed applicant for SERAQUEST MUMPS 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 MUMPS IGG?

The FDA product code for SERAQUEST MUMPS IGG is LJY.

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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: LJY)

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.

K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.K971857MUMPS IGG ELISA TESTYGull Laboratories, Inc.K961204MUMPS IGG TESTZeus Scientific, Inc.K925209MUMPS STATBiowhittaker Molecular Applications, Inc.K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, Inc.K897006PHARMACIA MUMPS IGG ELISAPharmacia Eni Diagnostics, 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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