The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Zonisamide Assay, Ark Zonisamide Calibrator, And Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003.
| Device ID | K091884 |
| 510k Number | K091884 |
| Device Name: | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 |
| Classification | Immunoassay, Anti-seizure Drug |
| Applicant | ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Contact | Johnny Valdez |
| Correspondent | Johnny Valdez ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Product Code | NWM |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2009-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003131 | K091884 | 000 |
| 00858724003070 | K091884 | 000 |
| 00858724003018 | K091884 | 000 |