Clearance Summary
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST received FDA 510(k) clearance under submission number K013263, sponsored by Fred Hutchinson Cancer Research Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-07-29.
- Submission: K013263
- Applicant / Sponsor: Fred Hutchinson Cancer Research Center
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2002-07-29
Classification & Regulation
This clearance is catalogued under FDA product code LKP and 21 CFR 866.5100, within the Immunology review panel as a Class II device.