K110899

Substantially Equivalent

GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

Applicant: Gold Standard Diagnostics
Product code: LYR
Advisory panel: Microbiology
Date received: 2011-03-30
Decision date: 2012-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

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.