Cleared Traditional

Alinity m HCV

K252102 · Abbott Molecular, Inc. · Microbiology
Sep 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K252102 is an FDA 510(k) clearance for the Alinity m HCV, a Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus (Class II — Special Controls, product code MZP), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on September 25, 2025, 84 days after receiving the submission on July 3, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3170.

Submission Details

510(k) Number K252102 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2025
Decision Date September 25, 2025
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MZP — Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3170