Clearance Summary
Great Basin Shiga Toxin Direct Test received FDA 510(k) clearance under submission number K152955, sponsored by Great Basin Scientific, 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 2016-03-22.
- Submission: K152955
- Applicant / Sponsor: Great Basin Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3990
- Decision date: 2016-03-22
Classification & Regulation
This clearance is catalogued under FDA product code PCH and 21 CFR 866.3990, within the Microbiology review panel as a Class II device.