Alinity m Resp-4-Plex— 510(k) K241573

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K241573 for Alinity m Resp-4-Plex, Substantially Equivalent on 2025-02-14. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2024-06-03
Decision date: 2025-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

More clearances from Abbott Molecular, Inc.

K252102 — Alinity m HCV2025-09-25
K243489 — Alinity m EBV (09N43-095)2025-07-28
K243485 — Alinity m CMV2025-07-01
K241921 — Alinity m BKV2025-03-24
K233349 — Alinity m HSV 1 & 2 / VZV2024-05-03

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