Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
|
510(k) Number |
K211748 |
Device Name |
Selux AST System; Model AST Gen 1.0 |
Applicant |
Selux Diagnostics, Inc |
56 Roland St, Suite 206 |
Charlestown,
MA
02129
|
|
Applicant Contact |
Eric Stern |
Correspondent |
PBO Consulting |
2212 East Pratt Street |
Baltimore,
MD
21231
|
|
Correspondent Contact |
Patricia Shrader |
Regulation Number | 866.1645
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2021 |
Decision Date | 04/19/2023 |
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
|
|
|