LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set— 510(k) K181464

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K181464 for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set, Substantially Equivalent on 2018-08-31. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2018-06-04
Decision date: 2018-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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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.