The following data is part of a premarket notification filed by Ark Diagnostics, Inc. with the FDA for Ark™ Fentanyl Ii Assay.
| Device ID | K200197 |
| 510k Number | K200197 |
| Device Name: | ARK™ Fentanyl II Assay |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 |
| Contact | Thomas Houts |
| Correspondent | Thomas Houts ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-02-26 |