K240445
- 510(k) number
- K240445
- Device name
- The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
- Applicant
- Thermo Fisher Scientific OH · US
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2024-05-16
- Date received
- 2024-02-15
- 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: K240445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.