NEOPROBE PORTABLE RADIOISOTOPE DETECTOR

Probe, Uptake, Nuclear

NEOPROBE CORP.

The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Neoprobe Portable Radioisotope Detector.

Pre-market Notification Details

Device IDK864263
510k NumberK864263
Device Name:NEOPROBE PORTABLE RADIOISOTOPE DETECTOR
ClassificationProbe, Uptake, Nuclear
Applicant NEOPROBE CORP. 2219 SUMMIT ST. Columbus,  OH  43201
ContactDavid Crockford
CorrespondentDavid Crockford
NEOPROBE CORP. 2219 SUMMIT ST. Columbus,  OH  43201
Product CodeIZD  
CFR Regulation Number892.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-29
Decision Date1986-12-29

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