The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Topiramate Assay, Ark Topiramate Calibrator And Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00.
| Device ID | K083799 |
| 510k Number | K083799 |
| Device Name: | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 |
| 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 | 2008-12-22 |
| Decision Date | 2009-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003124 | K083799 | 000 |
| 00858724003063 | K083799 | 000 |
| 00858724003001 | K083799 | 000 |