Clearance Summary
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT received FDA 510(k) clearance under submission number K971464, sponsored by Euro-Diagnostica 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 1997-10-29.
- Submission: K971464
- Applicant / Sponsor: Euro-Diagnostica AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 1997-10-29
Classification & Regulation
This clearance is catalogued under FDA product code DBL and 21 CFR 866.5660, within the Immunology review panel as a Class II device.