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FDA 510(k)

Alinity m EBV (09N43-095)

K-Number: K243489 · 2025-07-28

ApplicantAbbott Molecular, Inc.
Decision Date2025-07-28
Product CodeQLX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m EBV (09N43-095) 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 2025-07-28 under 510(k) number K243489. The device is classified under product code QLX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m EBV (09N43-095)?

Alinity m EBV (09N43-095) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K243489.

When did Alinity m EBV (09N43-095) receive FDA 510(k) clearance?

Alinity m EBV (09N43-095) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K243489.

Who is the listed applicant for Alinity m EBV (09N43-095)?

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 EBV (09N43-095)?

The FDA product code for Alinity m EBV (09N43-095) is QLX.

Other records listing Abbott Molecular, Inc. as applicant

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.

PMA P230003KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSPMA P170041Somatic gene mutation detection systemPMA P170005Somatic gene mutation detection systemPMA P150041Fluorescence in situ hybridization, chromosome 17p deletion (TP53)PMA P110012Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangementPMA P030052Unknown Device

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Related Devices (Code: QLX)

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.

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)Abbott Molecular, Inc.K203220cobas BKVRoche 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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