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FDA 510(k)

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY

K-Number: K010668 · 2001-07-05

ApplicantBayer Corp.
Decision Date2001-07-05
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM 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 2001-07-05 under 510(k) number K010668. 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 BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY?

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY is a medical device that received FDA 510(k) clearance on 2001-07-05. The listed applicant is Bayer Corp.. The 510(k) number is K010668.

When did BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY receive FDA 510(k) clearance?

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY received FDA 510(k) clearance on 2001-07-05, under 510(k) number K010668.

Who is the listed applicant for BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM 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 BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY?

The FDA product code for BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY is LFX.

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Other records listing Bayer Corp. 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.

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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