The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL— 510(k) K242657

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K242657 for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL, Substantially Equivalent on 2024-11-26. 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
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.