Clearance Summary
EntericBio Dx Assay received FDA 510(k) clearance under submission number K182703, sponsored by Serosep , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2019-06-19.
- Submission: K182703
- Applicant / Sponsor: Serosep , Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3990
- Decision date: 2019-06-19
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.