LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II— 510(k) K131441

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K131441 for LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II, Substantially Equivalent on 2013-08-09. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2013-05-20
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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