Clearance Summary
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra received FDA 510(k) clearance under submission number K183100, sponsored by Leica Biosystems Newcastle, Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2018-12-07.
- Submission: K183100
- Applicant / Sponsor: Leica Biosystems Newcastle, Limited
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2018-12-07
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.