Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL— 510(k) K221198
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K221198 for Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL, Substantially Equivalent on 2023-03-10. Applicant: Thermo Fisher Scientific.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- 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.