Device Listing 1396407832
Listing Summary#
- Listing key
- 1396407832
- Premarket submission
- K091653
- Device
- ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
- Applicant
- Ark Diagnostics, Inc.
- Product code
- ORI
- Decision date
- 2009-11-02