Clearance Summary
binx io CT/NG Assay and binx io CT/NG System received FDA 510(k) clearance under submission number K200533, sponsored by Binx Health, 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 2020-04-27.
- Submission: K200533
- Applicant / Sponsor: Binx Health, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3393
- Decision date: 2020-04-27
Classification & Regulation
This clearance is catalogued under FDA product code QEP and 21 CFR 866.3393, within the Microbiology review panel as a Class II device.