LEECO T4 QUANT DIAGNOSTICS TEST KIT

Radioimmunoassay, Total Thyroxine

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco T4 Quant Diagnostics Test Kit.

Pre-market Notification Details

Device IDK822399
510k NumberK822399
Device Name:LEECO T4 QUANT DIAGNOSTICS TEST KIT
ClassificationRadioimmunoassay, Total Thyroxine
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-10
Decision Date1982-09-13

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