Device Listing 1594724337
Listing Summary#
- Listing key
- 1594724337
- Premarket submission
- K101574
- Device
- ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
- Applicant
- Ark Diagnostics, Inc.
- Product code
- OTF
- Decision date
- 2010-11-23