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FDA 510(k)

SERAQUEST RUBELLA IGM

K-Number: K982281 · 1998-10-16

ApplicantQuest Intl., Inc.
Decision Date1998-10-16
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST RUBELLA 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 1998-10-16 under 510(k) number K982281. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST RUBELLA IGM?

SERAQUEST RUBELLA IGM is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Quest Intl., Inc.. The 510(k) number is K982281.

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

SERAQUEST RUBELLA IGM received FDA 510(k) clearance on 1998-10-16, under 510(k) number K982281.

Who is the listed applicant for SERAQUEST RUBELLA 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 RUBELLA IGM?

The FDA product code for SERAQUEST RUBELLA IGM is LFX.

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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: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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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