FDA 510(k)

Alinity m HCV

K-Number: K252102 · 2025-09-25

Decision Date2025-09-25

Product CodeMZP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Alinity m HCV 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 2025-09-25 under 510(k) number K252102. The device is classified under product code MZP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m HCV?

Alinity m HCV is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K252102.

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

Alinity m HCV received FDA 510(k) clearance on 2025-09-25, under 510(k) number K252102.

Who is the listed applicant for Alinity m HCV?

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 HCV?

The FDA product code for Alinity m HCV is MZP.

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 PAPILLOMAVIRUS PMA P170041Somatic gene mutation detection system PMA P170005Somatic gene mutation detection system PMA P150041Fluorescence in situ hybridization, chromosome 17p deletion (TP53)PMA P110012Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement PMA P030052Unknown Device

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Related Devices (Code: MZP)

K252484cobas HCVRoche Molecular Systems, Inc.K233352Aptima HCV Quant Dx AssayHologic, Inc.K221007cobas HCVRoche Molecular Systems, Inc.PMA P060030Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.PMA P150015Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.PMA P190025Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusAbbott Molecular, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.