Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL— 510(k) K211539
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K211539 for Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL, Substantially Equivalent on 2021-12-15. 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.