Clearance Summary
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) received FDA 510(k) clearance under submission number K994112, sponsored by Oncogene Science, 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 2000-09-29.
- Submission: K994112
- Applicant / Sponsor: Oncogene Science, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2000-09-29
Classification & Regulation
This clearance is catalogued under FDA product code NCW and 21 CFR 866.6010, within the Immunology review panel as a Class II device.