Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml— 510(k) K192729
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K192729 for Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml, Substantially Equivalent on 2019-11-06. Applicant: Thermo Fisher Scientific.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- Code JWY
- 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.