Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K193538 |
Device Name |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml |
Applicant |
Thermo Fisher Scientific |
1 Thermo Fisher Way |
Oakwood Village,
OH
44014 6
|
|
Applicant Contact |
Cynthia Knapp |
Correspondent |
Thermo Fisher Scientific |
1 Thermo Fisher Way |
Oakwood Village,
OH
44014 6
|
|
Correspondent Contact |
Cynthia Knapp |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2019 |
Decision Date | 03/12/2020 |
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
|
Recalls |
CDRH Recalls
|