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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 a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-03-24 under approval 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. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K241921.

When was Alinity m BKV approved by the FDA?

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

What company makes Alinity m BKV?

Alinity m BKV is manufactured by Abbott Molecular, Inc..

What is the FDA product code for Alinity m BKV?

The FDA product code for Alinity m BKV is QMI.

Other Devices by Abbott Molecular, Inc.

K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) K202977Alinity m STI Assay K222379Alinity m STI Assay K233349Alinity m HSV 1 & 2 / VZV K252102Alinity m HCV K243489Alinity m EBV (09N43-095)

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Related Devices (Code: QMI)

K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, 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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