The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Lamotrigine Assay, Calibrator & Control.
| Device ID | K101305 |
| 510k Number | K101305 |
| Device Name: | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL |
| Classification | Lamotrigine Assay |
| 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 | ORH |
| 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 | 2010-05-10 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003148 | K101305 | 000 |
| 00858724003087 | K101305 | 000 |
| 00858724003025 | K101305 | 000 |