Alinity m HCV— 510(k) K252102

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K252102 for Alinity m HCV, Substantially Equivalent on 2025-09-25. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code MZP
Device class: Class 2
Regulation: 21 CFR 866.3170
Advisory panel: Microbiology
Date received: 2025-07-03
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MZP

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More clearances from Abbott Molecular, Inc.

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K233349 — Alinity m HSV 1 & 2 / VZV2024-05-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.