Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
|
510(k) Number |
K211136 |
Device Name |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) |
Applicant |
BioMerieux, Inc |
595 Anglum Rd. |
Hazelwood,
MO
63042
|
|
Applicant Contact |
Esther Hernandez |
Correspondent |
BioMerieux, Inc |
595 Anglum Rd. |
Hazelwood,
MO
63042
|
|
Correspondent Contact |
Esther Hernandez |
Regulation Number | 866.1645
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/16/2021 |
Decision Date | 06/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|