Clearance Summary
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) received FDA 510(k) clearance under submission number K170028, sponsored by Dako Denmark A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-12-21.
- Submission: K170028
- Applicant / Sponsor: Dako Denmark A/S
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2017-12-21
Classification & Regulation
This clearance is catalogued under FDA product code MYA and 21 CFR 864.1860, within the Hematology review panel as a Class II device.