Clearance Summary
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 received FDA 510(k) clearance under submission number K013283, sponsored by Immuno Concepts, 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 2001-11-14.
- Submission: K013283
- Applicant / Sponsor: Immuno Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2001-11-14
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.