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FDA 510(k)

SERAQUEST EBV EA-D IGG TEST

K-Number: K091260 · 2009-06-08

ApplicantQuest Intl., Inc.
Decision Date2009-06-08
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST EBV EA-D IGG TEST 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 2009-06-08 under 510(k) number K091260. 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 EBV EA-D IGG TEST?

SERAQUEST EBV EA-D IGG TEST is a medical device that received FDA 510(k) clearance on 2009-06-08. The listed applicant is Quest Intl., Inc.. The 510(k) number is K091260.

When did SERAQUEST EBV EA-D IGG TEST receive FDA 510(k) clearance?

SERAQUEST EBV EA-D IGG TEST received FDA 510(k) clearance on 2009-06-08, under 510(k) number K091260.

Who is the listed applicant for SERAQUEST EBV EA-D IGG TEST?

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 EBV EA-D IGG TEST?

The FDA product code for SERAQUEST EBV EA-D IGG TEST 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.

K033915MODIFICATION TO SERAQUEST EB VCA IGGK033780MODIFICATION 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.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.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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