LEECO T3-RIA DIAGNOSTIC KIT

Radioimmunoassay, Total Triiodothyronine

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco T3-ria Diagnostic Kit.

Pre-market Notification Details

Device IDK830808
510k NumberK830808
Device Name:LEECO T3-RIA DIAGNOSTIC KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-14
Decision Date1983-04-08

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