The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL— 510(k) K243738
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K243738 for The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL, Substantially Equivalent on 2025-02-27. 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.