Device Listing 1021516410
Listing Summary#
- Listing key
- 1021516410
- Premarket submission
- K091884
- Device
- ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
- Applicant
- Ark Diagnostics, Inc.
- Product code
- NWM
- Decision date
- 2009-12-09