K231433
Substantially EquivalentThe Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
- Applicant
- Thermo Fisher Scientific
- Product code
- NGZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakwood Village, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.