Device Classification Name |
Enzyme Immunoassay, Opiates
|
510(k) Number |
K200197 |
Device Name |
ARK Fentanyl II Assay |
Applicant |
ARK Diagnostics, Inc. |
48089 Fremont Boulevard |
Fremont,
CA
94538
|
|
Applicant Contact |
Thomas Houts |
Correspondent |
ARK Diagnostics, Inc. |
48089 Fremont Boulevard |
Fremont,
CA
94538
|
|
Correspondent Contact |
Thomas Houts |
Regulation Number | 862.3650
|
Classification Product Code |
|
Date Received | 01/27/2020 |
Decision Date | 02/26/2020 |
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
|
|
|