Clearance Summary
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) received FDA 510(k) clearance under submission number K965022, sponsored by Dako 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 1997-11-06.
- Submission: K965022
- Applicant / Sponsor: Dako Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1997-11-06
Classification & Regulation
This clearance is catalogued under FDA product code DEH and 21 CFR 866.5550, within the Immunology review panel as a Class II device.