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FDA 510(k)

SERAQUEST EB VAC IGM

K-Number: K990977 · 1999-10-06

ApplicantQuest Intl., Inc.
Decision Date1999-10-06
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST EB VAC 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 1999-10-06 under 510(k) number K990977. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST EB VAC IGM?

SERAQUEST EB VAC IGM is a medical device that received FDA 510(k) clearance on 1999-10-06. The listed applicant is Quest Intl., Inc.. The 510(k) number is K990977.

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

SERAQUEST EB VAC IGM received FDA 510(k) clearance on 1999-10-06, under 510(k) number K990977.

Who is the listed applicant for SERAQUEST EB VAC 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 EB VAC IGM?

The FDA product code for SERAQUEST EB VAC IGM is LJN.

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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: LJN)

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.

K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, Inc.K973939IMMUNOWELL VCA IGM TESTGenbio

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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