K232310
- 510(k) number
- K232310
- Device name
- Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
- Applicant
- Thermo Fisher Scientific OH · US
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2023-10-31
- Date received
- 2023-08-02
- 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: K232310
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.