Clearance Summary
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES received FDA 510(k) clearance under submission number K962319, sponsored by Neoprobe Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-09-13.
- Submission: K962319
- Applicant / Sponsor: Neoprobe Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1320
- Decision date: 1996-09-13
Classification & Regulation
This clearance is catalogued under FDA product code IZD and 21 CFR 892.1320, within the Radiology review panel as a Class I device.