Clearance Summary
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM received FDA 510(k) clearance under submission number K981750, sponsored by Wieslab AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-07-22.
- Submission: K981750
- Applicant / Sponsor: Wieslab AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 1998-07-22
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.