The following data is part of a premarket notification filed by Ark Diagnostics, Inc. with the FDA for Ark Tramadol Assay.
| Device ID | K182280 |
| 510k Number | K182280 |
| Device Name: | ARK Tramadol Assay |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-22 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003834 | K182280 | 000 |
| 00812101031018 | K182280 | 000 |
| 00812101031025 | K182280 | 000 |
| 00812101031032 | K182280 | 000 |
| 00812101031049 | K182280 | 000 |
| 00812101031056 | K182280 | 000 |
| 00858724003773 | K182280 | 000 |
| 00858724003780 | K182280 | 000 |
| 00858724003797 | K182280 | 000 |
| 00858724003803 | K182280 | 000 |
| 00858724003810 | K182280 | 000 |
| 00858724003827 | K182280 | 000 |
| 00812101031001 | K182280 | 000 |