Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K193024 |
Device Name |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL |
Applicant |
Thermo Fisher Scientific |
One Thermo Fisher Way |
Oakwood Village,
OH
44146
|
|
Applicant Contact |
Cynthia Knapp |
Correspondent |
Thermo Fisher Scientific |
One Thermo Fisher Way |
Oakwood Village,
OH
44146
|
|
Correspondent Contact |
Cynthia Knapp |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/30/2019 |
Decision Date | 01/08/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|