Clearance Summary
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) received FDA 510(k) clearance under submission number K170005, 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: K170005
- 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 MXZ and 21 CFR 864.1860, within the Hematology review panel as a Class II device.