LEECO TESTO-QUANT DIAG. 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 Diag. Kit.

Pre-market Notification Details

Device IDK813059
510k NumberK813059
Device Name:LEECO TESTO-QUANT DIAG. KIT
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-30
Decision Date1981-11-16

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