The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Gabapentin Assay, Ark Gabepentin Califrator, And Ark Gabapentin Control Model5025-0001-00, 5025-0002-00, 5025-0003-0.
| Device ID | K101574 |
| 510k Number | K101574 |
| Device Name: | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 |
| Classification | Gabapentin 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 | OTF |
| 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 | 2010-06-07 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003261 | K101574 | 000 |
| 00858724003162 | K101574 | 000 |
| 00858724003100 | K101574 | 000 |
| 00858724003049 | K101574 | 000 |