VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192— 510(k) K001460

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K001460 for VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192, Substantially Equivalent on 2000-10-04. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2000-05-10
Decision date: 2000-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, 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.