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 IDK860003
510k NumberK860003
Device Name:LEECO TESTOSTERONE DIAGNOSTIC KIT
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
ContactJames P Lee
CorrespondentJames P Lee
LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield,  MI  48075
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-02
Decision Date1986-03-17

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