Clearance Summary
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) received FDA 510(k) clearance under submission number K160922, sponsored by Dako North America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2016-05-03.
- Submission: K160922
- Applicant / Sponsor: Dako North America, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2016-05-03
Classification & Regulation
This clearance is catalogued under FDA product code MXZ and 21 CFR 864.1860, within the Hematology review panel as a Class II device.