STRATUS CORTISOL FLUOROMETRIC ENZYME

Radioimmunoassay, Cortisol

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Cortisol Fluorometric Enzyme.

Pre-market Notification Details

Device IDK843183
510k NumberK843183
Device Name:STRATUS CORTISOL FLUOROMETRIC ENZYME
ClassificationRadioimmunoassay, Cortisol
Applicant AMERICAN DADE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-13
Decision Date1984-09-17

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