CORNING 4000 MULTI-WELL GAMMA COUNTER

Counter (beta, Gamma) For Clinical Use

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 4000 Multi-well Gamma Counter.

Pre-market Notification Details

Device IDK834508
510k NumberK834508
Device Name:CORNING 4000 MULTI-WELL GAMMA COUNTER
ClassificationCounter (beta, Gamma) For Clinical Use
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJJ  
CFR Regulation Number862.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-21
Decision Date1984-03-16

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