K232522 is an FDA 510(k) clearance for the ARK Levetiracetam II Assay. This device is classified as a Levetiracetam Assay (Class II - Special Controls, product code ORI).
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on February 27, 2024, 193 days after receiving the submission on August 18, 2023.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350. For The Quantitative Determination Of Levetiracetam In Human Serum Or Plasma..
| 510(k) Number | K232522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2023 |
| Decision Date | February 27, 2024 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | ORI - Levetiracetam Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |
| Definition | For The Quantitative Determination Of Levetiracetam In Human Serum Or Plasma. |