FOLATE 125I RADIOIMMUNOASSAY

Acid, Folic, Radioimmunoassay

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Folate 125i Radioimmunoassay.

Pre-market Notification Details

Device IDK803060
510k NumberK803060
Device Name:FOLATE 125I RADIOIMMUNOASSAY
ClassificationAcid, Folic, Radioimmunoassay
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGN  
CFR Regulation Number862.1295 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-12
Decision Date1980-12-22

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