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FDA 510(k)

SERAQUEST CMV IGM

K-Number: K982485 · 1999-01-13

ApplicantQuest Intl., Inc.
Decision Date1999-01-13
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST CMV 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 1999-01-13 under 510(k) number K982485. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST CMV IGM?

SERAQUEST CMV IGM is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Quest Intl., Inc.. The 510(k) number is K982485.

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

SERAQUEST CMV IGM received FDA 510(k) clearance on 1999-01-13, under 510(k) number K982485.

Who is the listed applicant for SERAQUEST CMV 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 CMV IGM?

The FDA product code for SERAQUEST CMV IGM is LFZ.

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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: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

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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