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FDA 510(k)

AXSYM CMV IGG ANTIBODY ASSAY

K-Number: K953943 · 1996-09-20

ApplicantAbbott Laboratories
Decision Date1996-09-20
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AXSYM CMV IGG 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 1996-09-20 under 510(k) number K953943. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM CMV IGG ANTIBODY ASSAY?

AXSYM CMV IGG ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Abbott Laboratories. The 510(k) number is K953943.

When did AXSYM CMV IGG ANTIBODY ASSAY receive FDA 510(k) clearance?

AXSYM CMV IGG ANTIBODY ASSAY received FDA 510(k) clearance on 1996-09-20, under 510(k) number K953943.

Who is the listed applicant for AXSYM CMV IGG 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 AXSYM CMV IGG ANTIBODY ASSAY?

The FDA product code for AXSYM CMV IGG ANTIBODY ASSAY is LFZ.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

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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