LEECO TESTO-QUANT 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 Testo-quant Diagnostic Kit.

Pre-market Notification Details

Device IDK803001
510k NumberK803001
Device Name:LEECO TESTO-QUANT 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 Received1980-11-25
Decision Date1981-01-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.