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FDA 510(k)

SERAQUEST CMV IGG

K-Number: K954191 · 1996-02-23

ApplicantQuest Intl., Inc.
Decision Date1996-02-23
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST CMV 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 1996-02-23 under 510(k) number K954191. 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 IGG?

SERAQUEST CMV IGG is a medical device that received FDA 510(k) clearance on 1996-02-23. The listed applicant is Quest Intl., Inc.. The 510(k) number is K954191.

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

SERAQUEST CMV IGG received FDA 510(k) clearance on 1996-02-23, under 510(k) number K954191.

Who is the listed applicant for SERAQUEST CMV 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 CMV IGG?

The FDA product code for SERAQUEST CMV IGG 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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