LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set— 510(k) K161139

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K161139 for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set, Substantially Equivalent on 2016-07-22. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2016-04-22
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

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.