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FDA 510(k)

Alinity m CMV

K-Number: K243485 · 2025-07-01

ApplicantAbbott Molecular, Inc.
Decision Date2025-07-01
Product CodePAB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m CMV 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 2025-07-01 under 510(k) number K243485. The device is classified under product code PAB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m CMV?

Alinity m CMV is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K243485.

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

Alinity m CMV received FDA 510(k) clearance on 2025-07-01, under 510(k) number K243485.

Who is the listed applicant for Alinity m CMV?

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 CMV?

The FDA product code for Alinity m CMV is PAB.

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: PAB)

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.

K252481cobas CMVRoche Molecular Systems, Inc.K243935Aptima CMV Quant AssayHologic, Inc.PMA P210029Cytomegalovirus (cmv) dna quantitative assayHologic, Inc.PMA P160041Cytomegalovirus (cmv) dna quantitative assayRoche Molecular Systems, Inc.PMA P110037Cytomegalovirus (cmv) dna quantitative assayRoche Molecular Systems, Inc.PMA P210022Cytomegalovirus (cmv) dna quantitative assayAbbott Molecular, 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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