Device Classification Name |
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
|
510(k) Number |
K183530 |
Device Name |
TruDiagnosis System |
Applicant |
Akonni Biosystems Inc. |
400 Sagner Ave, Suite 300 |
Frederick,
MD
21701
|
|
Applicant Contact |
Charles Daitch |
Correspondent |
MethodSense, Inc. |
1 Copley Parkway, Suite 410 |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Rita King |
Regulation Number | 862.3360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2018 |
Decision Date | 05/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|