Device Classification Name |
Susceptibility Test Discs, Antimicrobial
|
510(k) Number |
K203700 |
Device Name |
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 |
Applicant |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Wade Road |
Basingstroke,
GB
RG24 8PW
|
|
Applicant Contact |
Philip Brame |
Correspondent |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Wade Road |
Basingstroke,
GB
RG24 8PW
|
|
Correspondent Contact |
Amie Lovatt |
Regulation Number | 866.1620
|
Classification Product Code |
|
Date Received | 12/18/2020 |
Decision Date | 07/30/2021 |
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
|
|
|