The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Neoprobe Portable Radioisotope Detector.
| Device ID | K864263 |
| 510k Number | K864263 |
| Device Name: | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR |
| Classification | Probe, Uptake, Nuclear |
| Applicant | NEOPROBE CORP. 2219 SUMMIT ST. Columbus, OH 43201 |
| Contact | David Crockford |
| Correspondent | David Crockford NEOPROBE CORP. 2219 SUMMIT ST. Columbus, OH 43201 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1986-12-29 |