Vstrip H. pylori Antigen Rapid Test— 510(k) K183573

Substantially Equivalent

Panion & BF Biotech, Inc.

FDA 510(k) clearance K183573 for Vstrip H. pylori Antigen Rapid Test, Substantially Equivalent on 2019-03-14. Applicant: Panion & BF Biotech, Inc..

Clearance details

Applicant: Panion & BF Biotech, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2018-12-21
Decision date: 2019-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.