FEKAL CON-TRATE SYSTEM

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

TREND SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Fekal Con-trate System.

Pre-market Notification Details

Device IDK830769
510k NumberK830769
Device Name:FEKAL CON-TRATE SYSTEM
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant TREND SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-11
Decision Date1983-04-05

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