Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
|
510(k) Number |
K213899 |
Device Name |
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin |
Applicant |
bioMerieux, Inc. |
595 Anglum Road |
Hazelwood,
MO
63042
|
|
Applicant Contact |
Esther Hernandez |
Correspondent |
bioMerieux, Inc. |
595 Anglum Road |
Hazelwood,
MO
63042
|
|
Correspondent Contact |
Esther Hernandez |
Regulation Number | 866.1645
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/14/2021 |
Decision Date | 07/12/2022 |
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
|
|
|