Ark Diagnostics, Inc. · Class II · Cleared Dec 9, 2009
| K-number | K091884 |
| Device name | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 |
| Applicant | Ark Diagnostics, Inc. |
| Product code | NWM |
| Device class | Class II |
| Decision date | Dec 9, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.3350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov