K083799 is an FDA 510(k) clearance for the TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00. This device is classified as a Immunoassay, Anti-seizure Drug (Class II - Special Controls, product code NWM).
Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 16, 2009, 115 days after receiving the submission on December 22, 2008.
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 | K083799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2008 |
| Decision Date | April 16, 2009 |
| Days to Decision | 115 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. |