Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Alinity m Resp-4-Plex

K-Number: K241573 · 2025-02-14

ApplicantAbbott Molecular, Inc.
Decision Date2025-02-14
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity m Resp-4-Plex is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K241573. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m Resp-4-Plex?

Alinity m Resp-4-Plex is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K241573.

When did Alinity m Resp-4-Plex receive FDA 510(k) clearance?

Alinity m Resp-4-Plex received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241573.

Who is the listed applicant for Alinity m Resp-4-Plex?

The FDA 510(k) record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity m Resp-4-Plex?

The FDA product code for Alinity m Resp-4-Plex is QOF.

Other records listing Abbott Molecular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230003KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSPMA P170041Somatic gene mutation detection systemPMA P170005Somatic gene mutation detection systemPMA P150041Fluorescence in situ hybridization, chromosome 17p deletion (TP53)PMA P110012Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangementPMA P030052Unknown Device

View all 25 devices →

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices IncorporatedK252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑