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FDA 510(k)

Architect CMV IgG

K-Number: K220949 · 2022-10-27

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

Device Summary

Architect CMV IgG is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2022-10-27 under approval 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. It is manufactured by Abbott Laboratories. The 510(k) number is K220949.

When was Architect CMV IgG approved by the FDA?

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

What company makes Architect CMV IgG?

Architect CMV IgG is manufactured by Abbott Laboratories.

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)

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.