K091653 is an FDA 510(k) clearance for the ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00. This device is classified as a Levetiracetam Assay (Class II - Special Controls, product code ORI).
Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 2, 2009, 146 days after receiving the submission on June 9, 2009.
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 | K091653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2009 |
| Decision Date | November 02, 2009 |
| Days to Decision | 146 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. |