Clearance Summary
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance under submission number K230675, sponsored by Specific Diagnostics, 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 2024-06-20.
- Submission: K230675
- Applicant / Sponsor: Specific Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1650
- Decision date: 2024-06-20
Classification & Regulation
This clearance is catalogued under FDA product code SAN and 21 CFR 866.1650, within the Microbiology review panel as a Class II device.