Clearance Summary
Lumpipulse G CA19-9-N received FDA 510(k) clearance under submission number K191973, sponsored by Fujirebio Dianostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-10-22.
- Submission: K191973
- Applicant / Sponsor: Fujirebio Dianostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2019-10-22
Classification & Regulation
This clearance is catalogued under FDA product code NIG and 21 CFR 866.6010, within the Immunology review panel as a Class II device.