Device Listing 1855655044
Listing Summary#
- Listing key
- 1855655044
- Premarket submission
- K153596
- Device
- ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- Applicant
- Ark Diagnostics, Inc.
- Product code
- POX
- Decision date
- 2016-08-09