Alinity m BKV— 510(k) K241921

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K241921 for Alinity m BKV, Substantially Equivalent on 2025-03-24. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QMI
Device class: Class 2
Regulation: 21 CFR 866.3183
Advisory panel: Microbiology
Date received: 2024-07-01
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QMI

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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.