K091884 is an FDA 510(k) clearance for the ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003. 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 December 9, 2009, 168 days after receiving the submission on June 24, 2009.
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 | K091884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2009 |
| Decision Date | December 09, 2009 |
| Days to Decision | 168 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. |