Clearance Summary
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack received FDA 510(k) clearance under submission number K143651, sponsored by Focus Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2015-03-18.
- Submission: K143651
- Applicant / Sponsor: Focus Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.2680
- Decision date: 2015-03-18
Classification & Regulation
This clearance is catalogued under FDA product code PGX and 21 CFR 866.2680, within the Microbiology review panel as a Class II device.