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FDA 510(k)

CYTOMEGALOVIRUS (CMV) ELISA

K-Number: K904456 · 1991-04-03

ApplicantVirotech, Inc.
Decision Date1991-04-03
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS (CMV) ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Virotech, Inc.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K904456. 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 CYTOMEGALOVIRUS (CMV) ELISA?

CYTOMEGALOVIRUS (CMV) ELISA is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Virotech, Inc.. The 510(k) number is K904456.

When did CYTOMEGALOVIRUS (CMV) ELISA receive FDA 510(k) clearance?

CYTOMEGALOVIRUS (CMV) ELISA received FDA 510(k) clearance on 1991-04-03, under 510(k) number K904456.

Who is the listed applicant for CYTOMEGALOVIRUS (CMV) ELISA?

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

What is the FDA product code for CYTOMEGALOVIRUS (CMV) ELISA?

The FDA product code for CYTOMEGALOVIRUS (CMV) ELISA 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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