K231994

Substantially Equivalent

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

Applicant: Thermo Fisher Scientific
Product code: JWY
Advisory panel: Microbiology
Date received: 2023-07-05
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

Download summary PDF View on FDA.gov ↗

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