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FDA 510(k)

SERAQUEST EB NA IGG

K-Number: K991975 · 1999-11-02

ApplicantQuest Intl., Inc.
Decision Date1999-11-02
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST EB NA 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 1999-11-02 under 510(k) number K991975. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST EB NA IGG?

SERAQUEST EB NA IGG is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Quest Intl., Inc.. The 510(k) number is K991975.

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

SERAQUEST EB NA IGG received FDA 510(k) clearance on 1999-11-02, under 510(k) number K991975.

Who is the listed applicant for SERAQUEST EB NA 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 EB NA IGG?

The FDA product code for SERAQUEST EB NA IGG is LSE.

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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: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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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