MATCHED COMPONENT SET FOR RADIOIMMUNO-

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Matched Component Set For Radioimmuno-.

Pre-market Notification Details

Device IDK843635
510k NumberK843635
Device Name:MATCHED COMPONENT SET FOR RADIOIMMUNO-
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-17
Decision Date1984-09-28

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