510(k) K093974— ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
Substantially EquivalentOsmetech Molecular Diagnostics
Clearance details
- Applicant
- Osmetech Molecular Diagnostics
- Product code
- Code NPQ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.