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FDA 510(k)

Alinity m BKV

K-Number: K241921 · 2025-03-24

ApplicantAbbott Molecular, Inc.
Decision Date2025-03-24
Product CodeQMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m BKV is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K241921. The device is classified under product code QMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m BKV?

Alinity m BKV is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K241921.

When did Alinity m BKV receive FDA 510(k) clearance?

Alinity m BKV received FDA 510(k) clearance on 2025-03-24, under 510(k) number K241921.

Who is the listed applicant for Alinity m BKV?

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

What is the FDA product code for Alinity m BKV?

The FDA product code for Alinity m BKV is QMI.

Other records listing Abbott Molecular, Inc. as applicant

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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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