INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST— 510(k) K024360

Substantially Equivalent

Alfa Scientific Designs, Inc.

FDA 510(k) clearance K024360 for INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST, Substantially Equivalent on 2003-06-10. Applicant: Alfa Scientific Designs, Inc..

Clearance details

Applicant: Alfa Scientific Designs, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2002-12-30
Decision date: 2003-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, 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.