Clearance Summary
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack received FDA 510(k) clearance under submission number K163085, sponsored by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2017-02-14.
- Submission: K163085
- Applicant / Sponsor: Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3130
- Decision date: 2017-02-14
Classification & Regulation
This clearance is catalogued under FDA product code OZN and 21 CFR 866.3130, within the Microbiology review panel as a Class II device.