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FDA 510(k)

Architect CMV IgG

K-Number: K220949 · 2022-10-27

ApplicantAbbott Laboratories
Decision Date2022-10-27
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Architect CMV IgG is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2022-10-27 under 510(k) number K220949. 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 Architect CMV IgG?

Architect CMV IgG is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Abbott Laboratories. The 510(k) number is K220949.

When did Architect CMV IgG receive FDA 510(k) clearance?

Architect CMV IgG received FDA 510(k) clearance on 2022-10-27, under 510(k) number K220949.

Who is the listed applicant for Architect CMV IgG?

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 Architect CMV IgG?

The FDA product code for Architect CMV IgG 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.

K220911Elecsys 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.

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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