PYLORI IGG— 510(k) K033067

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K033067 for PYLORI IGG, Substantially Equivalent on 2003-11-26. Applicant: Trinity Biotech USA.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2003-09-29
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, 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.