Submission Details
| 510(k) Number | K232522 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ARK Levetiracetam II Assay
Feb 2024
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K232522 is an FDA 510(k) clearance for the ARK Levetiracetam II Assay, 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 review panel. Regulated under 21 CFR 862.3350.
Device Classification
| 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. |
Manufacturer
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