Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)— 510(k) K230935
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K230935 for Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae), Substantially Equivalent on 2023-06-30. 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.