HELICOBACTER PYLORI ELISA IGG TEST KIT— 510(k) K110745
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K110745 for HELICOBACTER PYLORI ELISA IGG TEST KIT, Substantially Equivalent on 2012-03-02. Applicant: Gold Standard Diagnostics. Device class: 1.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code LYR
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
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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.