510(k) K864263
K864263 is an FDA 510(k) premarket notification submitted by Neoprobe Corp. for the device "NEOPROBE PORTABLE RADIOISOTOPE DETECTOR". The FDA issued a decision of Substantially Equivalent on December 29, 1986. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Neoprobe Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1986
- Date Received
- October 29, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type