Device Listing 1277011576
Listing Summary#
- Listing key
- 1277011576
- Premarket submission
- K163085
- Device
- Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
- Product code
- OZN
- Decision date
- 2017-02-14