K243738
- 510(k) number
- K243738
- Device name
- The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- Applicant
- Thermo Fisher Scientific OH · US
- Product code
- NGZ — Susceptibility Test Plate, Antifungal
- Decision date
- 2025-02-27
- Date received
- 2024-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.