Device Classification Name |
levetiracetam assay
|
510(k) Number |
K232522 |
Device Name |
ARK Levetiracetam II Assay |
Applicant |
ARK Diagnostics, Inc. |
48089 Fremont Boulevard |
Fremont,
CA
94538
|
|
Applicant Contact |
Dionne Labatore |
Correspondent |
ARK Diagnostics, Inc. |
48089 Fremont Boulevard |
Fremont,
CA
94538
|
|
Correspondent Contact |
Dionne Labatore |
Regulation Number | 862.3350
|
Classification Product Code |
|
Date Received | 08/18/2023 |
Decision Date | 02/27/2024 |
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
|
|
|