The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Levetiracetam Assay, Ark Levetiracetam Calibrator And Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00.
| Device ID | K091653 |
| 510k Number | K091653 |
| Device Name: | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 |
| Classification | Levetiracetam 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 | ORI |
| 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 | 2009-06-09 |
| Decision Date | 2009-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003155 | K091653 | 000 |
| 00858724003094 | K091653 | 000 |
| 00858724003032 | K091653 | 000 |