The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
Thermo Fisher Scientific · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- Oakwood Village
- Advisory committee description
- Microbiology
- Address 1
- 1 Thermofisher Way
- Statement or summary
- Statement
- Product code
- JWY
- Zip code
- 44146
- Applicant
- Thermo Fisher Scientific
- Decision date
- 2025-02-10
- Decision code
- SESE
- Country code
- US
- Advisory committee
- MI
- Contact
- Joel Mathew
- K number
- K243201
- State
- OH
- Date received
- 2024-10-01
- Review advisory committee
- MI
- Postal code
- 44146
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
- Harmonized identifiers (openFDA)
- Device name
- Manual Antimicrobial Susceptibility Test Systems
- Medical specialty description
- Microbiology
- Regulation number
- 866.1640
- Device class
- 2
- Registration number
- 2919016, 1530126, 3003750284, 8021914, 1924669, 9615754, 1119779, 3013661582, 3012389632
- FEI number
- 3002806332, 2919016, 1000515493, 3008237827, 3003750284, 1924669, 1119779, 3013661582, 3012389632