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FDA 510(k)

Alinity m Resp-4-Plex

K-Number: K241573 · 2025-02-14

ApplicantAbbott Molecular, Inc.
Decision Date2025-02-14
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m Resp-4-Plex is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-02-14 under approval number K241573. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m Resp-4-Plex?

Alinity m Resp-4-Plex is a medical device that received FDA 510(k) clearance on 2025-02-14. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K241573.

When was Alinity m Resp-4-Plex approved by the FDA?

Alinity m Resp-4-Plex received FDA 510(k) clearance on 2025-02-14, under approval number K241573.

What company makes Alinity m Resp-4-Plex?

Alinity m Resp-4-Plex is manufactured by Abbott Molecular, Inc..

What is the FDA product code for Alinity m Resp-4-Plex?

The FDA product code for Alinity m Resp-4-Plex is QOF.

Other Devices by Abbott Molecular, Inc.

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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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