LEECO TESTOSTERONE DIAGNOSTIC KIT

Radioimmunoassay, Testosterones And Dihydrotestosterone

LEECO DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK830512
510k NumberK830512
Device Name:LEECO TESTOSTERONE DIAGNOSTIC KIT
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-17
Decision Date1983-04-05

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