Clearance Summary
SCANLISA HUMAN CRP ELISA KIT received FDA 510(k) clearance under submission number K894573, sponsored by Immuntech A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1989-08-10.
- Submission: K894573
- Applicant / Sponsor: Immuntech A/S
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 1989-08-10
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.