PYLORISCREEN— 510(k) K925190
Substantially EquivalentNew Horizons Diagnostics Co.
FDA 510(k) clearance K925190 for PYLORISCREEN, Substantially Equivalent on 1993-03-23. Applicant: New Horizons Diagnostics Co..
Clearance details
- Applicant
- New Horizons Diagnostics Co.
- Product code
- Code LYR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.