Clearance Summary
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). received FDA 510(k) clearance under submission number K193393, sponsored by Leica Biosystems Newcastle, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-03-06.
- Submission: K193393
- Applicant / Sponsor: Leica Biosystems Newcastle, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2020-03-06
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.