Clearance Summary
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR received FDA 510(k) clearance under submission number K984034, sponsored by Zeus Scientific, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-11-30.
- Submission: K984034
- Applicant / Sponsor: Zeus Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 1998-11-30
Classification & Regulation
This clearance is catalogued under FDA product code MOB and 21 CFR 866.5660, within the Immunology review panel as a Class II device.