Clearance Summary
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET received FDA 510(k) clearance under submission number K994110, sponsored by Diasorin/American Standard Companies. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1999-12-21.
- Submission: K994110
- Applicant / Sponsor: Diasorin/American Standard Companies
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5600
- Decision date: 1999-12-21
Classification & Regulation
This clearance is catalogued under FDA product code DFC and 21 CFR 866.5600, within the Immunology review panel as a Class II device.