OREIA-Q-TY, ENZYME IMMUNOASSAY

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

ORGANON, INC.

The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Oreia-q-ty, Enzyme Immunoassay.

Pre-market Notification Details

Device IDK802693
510k NumberK802693
Device Name:OREIA-Q-TY, ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant ORGANON, 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 Received1980-10-30
Decision Date1980-12-10

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