Clearance Summary
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 received FDA 510(k) clearance under submission number K081286, sponsored by Dako North America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-05-08.
- Submission: K081286
- Applicant / Sponsor: Dako North America, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2009-05-08
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.