MATCHED COMPONENT SET RADIOIMMUNOASSAY

Radioimmunoassay, Testosterones And Dihydrotestosterone

CAMBRIDGE MEDICAL TECHNOLOGY

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

Pre-market Notification Details

Device IDK841042
510k NumberK841042
Device Name:MATCHED COMPONENT SET RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-12
Decision Date1984-04-19

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