Clearance Summary
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT received FDA 510(k) clearance under submission number K983122, sponsored by Mill-Rose Laboratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1998-10-30.
- Submission: K983122
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1998-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.