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 i Toxo IgM

K-Number: K233932 · 2024-08-30

ApplicantAbbott Laboratories
Decision Date2024-08-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alinity i Toxo IgM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K233932. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity i Toxo IgM?

Alinity i Toxo IgM is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Abbott Laboratories. The 510(k) number is K233932.

When did Alinity i Toxo IgM receive FDA 510(k) clearance?

Alinity i Toxo IgM received FDA 510(k) clearance on 2024-08-30, under 510(k) number K233932.

Who is the listed applicant for Alinity i Toxo IgM?

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

What is the FDA product code for Alinity i Toxo IgM?

The FDA product code for Alinity i Toxo IgM is LGD.

Other records listing Abbott Laboratories 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 P120008KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK252424Anti-HCV NextPMA P910007Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P980007Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgG

View all 36 devices →

Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics

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.

↑