Clearance Summary
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT received FDA 510(k) clearance under submission number K980855, sponsored by Dpc Cirrus. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-04-21.
- Submission: K980855
- Applicant / Sponsor: Dpc Cirrus
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1998-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DHX and 21 CFR 866.6010, within the Immunology review panel as a Class II device.