GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT— 510(k) K110899
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K110899 for GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT, Substantially Equivalent on 2012-02-01. Applicant: Gold Standard Diagnostics.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code LYR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, 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.