Clearance Summary
AESKULISA ANA HEP-2, REF 30-7115US received FDA 510(k) clearance under submission number K081104, sponsored by Aesku Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2008-05-02.
- Submission: K081104
- Applicant / Sponsor: Aesku Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2008-05-02
Classification & Regulation
This clearance is catalogued under FDA product code LKJ and 21 CFR 866.5100, within the Immunology review panel as a Class II device.