Device Listing 2059670834
Listing Summary#
- Listing key
- 2059670834
- Premarket submission
- K181436
- Device
- OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- Applicant
- SEKISUI Diagnostics, LLC
- Product code
- KTN
- Decision date
- 2018-06-22