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510(k) K252102

Alinity m HCV by Abbott Molecular, Inc. — Product Code MZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
July 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device Class
Class II
Regulation Number
866.3170
Review Panel
MI
Submission Type

Other clearances by Abbott Molecular, Inc.

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  • K241921 — Alinity m BKV (March 24, 2025)
  • K241573 — Alinity m Resp-4-Plex (February 14, 2025)
  • K243410 — simpli-COLLECT STI Test (January 30, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N (July 15, 2022)
  • K202977 — Alinity m STI Assay (April 29, 2022)

Other clearances for product code MZP

  • K252484 — cobas HCV (November 3, 2025)
  • K233352 — Aptima HCV Quant Dx Assay (July 24, 2024)
  • K221007 — cobas HCV (November 4, 2022)