Clearance Summary
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS received FDA 510(k) clearance under submission number K870107, sponsored by Diagnostic Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-02-10.
- Submission: K870107
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1987-02-10
Classification & Regulation
This clearance is catalogued under FDA product code DBF and 21 CFR 866.5340, within the Immunology review panel as a Class II device.