Device Listing 1137811977
Listing Summary#
- Listing key
- 1137811977
- Premarket submission
- K143651
- Device
- Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.
- Product code
- PGX
- Decision date
- 2015-03-18