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FDA 510(k)

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

K-Number: K982027 · 1998-11-25

ApplicantDiaSorin, Inc.
Decision Date1998-11-25
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K982027. 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 MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY?

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is DiaSorin, Inc.. The 510(k) number is K982027.

When did MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY receive FDA 510(k) clearance?

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY received FDA 510(k) clearance on 1998-11-25, under 510(k) number K982027.

Who is the listed applicant for MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY?

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

What is the FDA product code for MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY?

The FDA product code for MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY is LFZ.

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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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