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 a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-09-25 under approval 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. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K252102.

When was Alinity m HCV approved by the FDA?

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

What company makes Alinity m HCV?

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

What is the FDA product code for Alinity m HCV?

The FDA product code for Alinity m HCV is MZP.

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 K243489Alinity m EBV (09N43-095) K243485Alinity m CMV

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Related Devices (Code: MZP)

K221007cobas HCVRoche Molecular Systems, Inc. K233352Aptima HCV Quant Dx AssayHologic, Inc. K252484cobas HCVRoche Molecular Systems, Inc. PMA P100017Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusAbbott Molecular, Inc. PMA P150015Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc. PMA P060030Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche 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.