The following data is part of a premarket notification filed by Ark Diagnostics, Inc. with the FDA for Ark Eddp Assay.
| Device ID | K182779 |
| 510k Number | K182779 |
| Device Name: | ARK EDDP Assay |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 |
| Contact | Cherry Mun |
| Correspondent | Cherry Mun ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003926 | K182779 | 000 |
| 00858724003919 | K182779 | 000 |
| 00858724003902 | K182779 | 000 |
| 00858724003896 | K182779 | 000 |
| 00858724003889 | K182779 | 000 |
| 00858724003872 | K182779 | 000 |
| 00858724003865 | K182779 | 000 |
| 00858724003858 | K182779 | 000 |
| 00858724003841 | K182779 | 000 |