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FDA 510(k)

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY

K-Number: K954318 · 1996-05-14

ApplicantAbbott Laboratories
Decision Date1996-05-14
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-05-14 under 510(k) number K954318. 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 ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY?

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1996-05-14. The listed applicant is Abbott Laboratories. The 510(k) number is K954318.

When did ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY receive FDA 510(k) clearance?

ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY received FDA 510(k) clearance on 1996-05-14, under 510(k) number K954318.

Who is the listed applicant for ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY?

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

What is the FDA product code for ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY?

The FDA product code for ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY is LFX.

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Other records listing Abbott Laboratories 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.

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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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