ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-00 — Ark Diagnostics, Inc. (510(k) K091884
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-00 — Ark Diagnostics, Inc. (510(k) K091884 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-00; Applican
| Device name | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-00 |
|---|---|
| Applicant | Ark Diagnostics, Inc. |
| Clearance track | 510(k) |
| Submission number | K091884 |
| Decision | Substantially Equivalent |
| Decision date | 2009-12-09 |
| Date received | 2009-06-24 |
| Product code | NWM |
| Device class | 2 |
| Medical specialty | Clinical Toxicology |
| Applicant location | CA, US |
| Source | openFDA device |
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