Clearance Summary
ANA/LITE-HEP-2 TEST SYSTEM received FDA 510(k) clearance under submission number K852231, sponsored by Immuno-Products Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1985-07-10.
- Submission: K852231
- Applicant / Sponsor: Immuno-Products Industries
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1985-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LJM and 21 CFR 866.5100, within the Immunology review panel as a Class II device.