PYLORISCREEN— 510(k) K925190

Name: FDA 510(k) clearance K925190
Creator: U.S. Food and Drug Administration
Published: 1993-03-23

Substantially Equivalent

New Horizons Diagnostics Co.

FDA 510(k) clearance K925190 for PYLORISCREEN, Substantially Equivalent on 1993-03-23. Applicant: New Horizons Diagnostics Co.. Device class: 1.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1992-10-14
Decision date: 1993-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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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.