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FDA 510(k)

MODIFICATION TO SERAQUEST EB VCA IGG

K-Number: K033915 · 2004-01-16

ApplicantQuest Intl., Inc.
Decision Date2004-01-16
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SERAQUEST EB VCA 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 2004-01-16 under 510(k) number K033915. 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 MODIFICATION TO SERAQUEST EB VCA IGG?

MODIFICATION TO SERAQUEST EB VCA IGG is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Quest Intl., Inc.. The 510(k) number is K033915.

When did MODIFICATION TO SERAQUEST EB VCA IGG receive FDA 510(k) clearance?

MODIFICATION TO SERAQUEST EB VCA IGG received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033915.

Who is the listed applicant for MODIFICATION TO SERAQUEST EB VCA 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 MODIFICATION TO SERAQUEST EB VCA IGG?

The FDA product code for MODIFICATION TO SERAQUEST EB VCA 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 TESTK033780MODIFICATION TO SERAQUEST VCA IGMK023593SERAQUEST ANTI-THYROID PEROXIDASE (TPO)K023592SERAQUEST ANTI-THYROGLOBULINK003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEMK991975SERAQUEST EB NA IGG

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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.K062211BIOPLEX 2200 EBV IGG PANEL FOR 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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