Clearance Summary
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system received FDA 510(k) clearance under submission number K251875, sponsored by Affinity Biosensors, 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 2025-10-27.
- Submission: K251875
- Applicant / Sponsor: Affinity Biosensors, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1650
- Decision date: 2025-10-27
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.