The following data is part of a premarket notification filed by Ark Diagnostics, Inc. with the FDA for Ark Oxcarbazepine Metabolite Assay, Ark Oxcarbazepine Metabolite Calibrator, Ark Oxcarbazepine Metabolite Control.
| Device ID | K153596 |
| 510k Number | K153596 |
| Device Name: | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control |
| Classification | Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Applicant | ARK DIAGNOSTICS, INC. 48089 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Kenneth C. Kasper |
| Correspondent | Kenneth C. Kasper ARK DIAGNOSTICS, INC. 48089 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | POX |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858724003322 | K153596 | 000 |
| 00858724003315 | K153596 | 000 |
| 00858724003308 | K153596 | 000 |