Clearance Summary
ELECSYS CEA ON THE ELECSYS 1010 received FDA 510(k) clearance under submission number K980887, sponsored by Boehringer Mannheim 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 1998-06-29.
- Submission: K980887
- Applicant / Sponsor: Boehringer Mannheim Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1998-06-29
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.