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FDA 510(k)

ADVIA CENTAUR RUBELLA IGG ASSAY

K-Number: K003412 · 2001-04-13

ApplicantBayer Corp.
Decision Date2001-04-13
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR RUBELLA IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K003412. 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 ADVIA CENTAUR RUBELLA IGG ASSAY?

ADVIA CENTAUR RUBELLA IGG ASSAY is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Bayer Corp.. The 510(k) number is K003412.

When did ADVIA CENTAUR RUBELLA IGG ASSAY receive FDA 510(k) clearance?

ADVIA CENTAUR RUBELLA IGG ASSAY received FDA 510(k) clearance on 2001-04-13, under 510(k) number K003412.

Who is the listed applicant for ADVIA CENTAUR RUBELLA IGG ASSAY?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA CENTAUR RUBELLA IGG ASSAY?

The FDA product code for ADVIA CENTAUR RUBELLA IGG ASSAY is LFX.

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Other records listing Bayer Corp. as applicant

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K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE 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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