Device Classification Name |
drug metabolizing enzyme genotyping systems
|
510(k) Number |
K101683 |
Device Name |
INFINITI CYP2C19 ASSAY |
Applicant |
AUTOGENOMICS, INCORPORATED |
2980 SCOTT STREET |
VISTA,
CA
92081
|
|
Applicant Contact |
EVELYN G LOPEZ |
Correspondent |
AUTOGENOMICS, INCORPORATED |
2980 SCOTT STREET |
VISTA,
CA
92081
|
|
Correspondent Contact |
EVELYN G LOPEZ |
Regulation Number | 862.3360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2010 |
Decision Date | 10/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|