Clearance Summary
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) received FDA 510(k) clearance under submission number K061360, sponsored by Lab Vision Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2006-06-27.
- Submission: K061360
- Applicant / Sponsor: Lab Vision Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2006-06-27
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.