K201089 is an FDA 510(k) clearance for the ARK Lacosamide Assay. This device is classified as a Immunoassay, Anti-seizure Drug (Class II - Special Controls, product code NWM).
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 5, 2021, 469 days after receiving the submission on April 23, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350. To Aid In Management Of Patients Treated With Anti-seizure Drug..
| 510(k) Number | K201089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2020 |
| Decision Date | August 05, 2021 |
| Days to Decision | 469 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NWM - Immunoassay, Anti-seizure Drug |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |
| Definition | To Aid In Management Of Patients Treated With Anti-seizure Drug. |